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QC Inspector – Tulsa, Oklahoma -CRC-Evans Pipeline International Inc.

Purpose of Position: Perform inspection, checks, test and sampling procedures of incoming materials, parts and components used for manufacture job. Inspect and report all parts return from the project before return to the warehouse/stock.  Reports to the QC Manager

Major Responsibilities:

Produce quality work on time Insure associates observe in-line quality protocols
• Execute in-line quality protocols, final QC process and procedure
• Inspect and test products/materials per assigned work order (WO)
• Provide WO status to QC inspector Team Lead
• Approves incoming materials and finished products by confirming specifications, conducting visual and measurements test; rejecting and returning unacceptable materials to vendor/suppliers,      returning internal materials for re-work, documents all re-works
• Willing to be trained on, inspection techniques, quality methodologies and use of inspection apparatus and testing equipment
• Use appropriate forms for all materials transactions such as Return to Stock, Scrap, materials parts Return to vendor/suppliers.
• Keeps measurements equipment operating and up to calibration date, tracking all digital and mechanical measurements equipment record on Quality database
• Issue the relevant Quality record and, when necessary, writes and sends to QC Inspector Team Lead/Supervisor/Manager nonconform report
• Documents inspection result by completing reports and logs, summarizing re-work and waste, inputting data into Quality database.
• Comply with company police and procedures
• Willing to work overtime and on weekend
• Performing others duties as assigned
• Maintains safe and healthy work environments by following company EHS policy standards and procedures

Education Required:   H.S. Diploma

Work Experience Required:  3-year minimum experience in mechanical manufacturing industry, preferable in Oil and Gas industry is a plus.

Skills and Knowledge Required:

• Possess working knowledge of inspection techniques, tools and equipment used in the inspection and testing mechanical parts received from vendor/suppliers or produced in house from machine shop and prefabrication area.
• Understand quality methodologies
• Able to apply QA/QC theory to achieve actual quality goals
• Able to interpret blueprints/schematic, inspect and test final product to drawings and required standards with limited supervision
• Work well with diversified Quality Assurance/Control and Manufacturing
• Able to communicate and report effectively to QC Inspector Team Lead, Supervisor, Manager staff and peers.
• Good attitude and be able to work alone or as team as well.

Key Stanley Black and Decker Qualities Required:

Accountability

– Makes and meets commitments
– Accepts responsibility
– Has a passion for excellence
– Focus on execution, Hates to lose…loves to win
– Passionately embraces the principles of SFS

Integrity
– Operates in accordance with our business conduct policies
– Is honest, fair and trustworthy in all activities and relationships
– Strives to create a safe workplace and to protect the environment
– Adheres to the highest standards of business ethics
– Encourages others to raise concerns

Respect
– Treats others with respect and candor
– Actively supports a diverse, inclusive work environment
– Builds positive work relationships
– Shares knowledge and encourages the development of others
– Promotes teamwork

Vision
– Creates clear, simple reality-based customer-focused strategy and goals
– Builds trust and commitment though candid communication
– Energizes and excites others
– Is passionate about the business and the company

Boundaryless
– Is open to ideas from anywhere

– Participates openly and constructively without alienating others
– Has a global perspective
– Breaks through “turf” issues
– Collaborative, works for the good of the team
– Seeks out best practices and puts them to use

Stretch
– Sets aggressive goals and celebrates progress
– Continually strives to be best in class
– Has a passion to exceed customer expectations
– Builds high performing teams

Speed
– Has a bias for action
– Takes calculated risks based on quality data
– Drives standardization and simplification
– Fights to eliminate bureaucracy and reduce complexity

 

QA Manager – Woodcliff Lake, NJ – Long Term Contract

Position: QA Manager
Location: Woodcliff Lake, NJ
Length: Long Term Contract

Job Description:
Establish a framework for the design, development, maintenance and execution of automated tests within a Development Operations (Dev Ops) mode
Identify best practices in the design and development of Dev Ops test automation
Work with the Quality Assurance (QA) Team, Service Customer and technical teams to implement acceptable roadmap solutions for rapid development automation testing
Prepare and update documentations on Dev Ops test automation strategy and operating guidelines
Enhance the Dev Ops test automation skills within the QA team

 

Skills:
Qualifications:
Minimum seven years of relevant experience in the design and development of automated tests  within in an enterprise environment
Bachelor’s degree from an accredited college or university
Experience in Agile / Rapid Development Life Cycle methodologies;  certification preferred
Experience in quality assurance processes, methodologies and implementation
Experience in automated testing tools and hands-on experience in Dev Ops automated tests
Experience with programming languages such as SQL, VB, PERL and various shells

If you are interested, please reach out to:

Abhi Roy | Sr. Technical Recruiter | Panzer Solutions, LLC
50 Washington Street | 9th Floor, SONO Corporate Center | Norwalk CT 06854 USA
Direct: 2034429707  Office: 203 -652 -1444 Ext 309; | Fax: 203-286-1457 | Email: Abhi.roy@panzersols.com

Technical QA Lead (Data Migration & Test Data Management) – Plano, TX – 12+ month – W2 only!

Please have a glance on below requirement and let me know if you would like to pursue? If Yes, Please share your updated resume.

Position: Technical QA Lead (Data Migration & Test Data Management)
Location: Plano, TX (100% On Site)
Duration: 12+ month (will go long term)W2 Only!!

Notes:
Managing QA Leads of outsourced teams – Experience implementing, driving, and executing testing strategies
Experience working on large data migrations projects – This role is focused on leading testing efforts of data moving from legacy system to a new platform
Test Data Management tool experience (Informatica TDM or similar) – keeping data in sync across multiple systems and driving efficiency
Of course Finance/Banking/Loan servicing experience will put candidates above others

PROJECT SUMMARY
This senior level resource will lead data migration testing efforts for a large business transformational program in a financial services organization.  The purpose of the Core Receivables Migration Testing is to assess the accuracy of migration trials by financial and operational reconciliation as well as transactional testing, verifying that the data delivered by the migration process is of sufficient quality to support the business.  The scope will include Source Extract, reconciliation and “to-be system” transaction based validation.

REQUIREMENTS:
8-10 years of experience leading all phases of QA effort required to execute large business transformation projects
Experience strategizing and implementing Test Data Management process and/or tool to increase testing efficiency
Experience using API automation to create/inject “production-like” test data into test environments to meet testing needs
Identifying and analyzing quality risks
Determining testing scope using risk-based testing approach
Ability to react to changing project plans and come up with creative alternatives
Preparing, managing time estimates and fixed bid deliverables (SOW)
Reviewing supplier deliverables and providing feedback and direction
Assessing Risk to schedule, cost, or quality on project and testing engagement
Preparing and managing the project testing schedule
Preparing and facilitating the implementation of test plans
Defect Management and Analysis
Excellent communication (written, verbal)
Organizational, planning, and analytical skills
Ability to work in a collaborative “team-oriented” environment

—————————————————————————————–
Thanks & Best Regards Zubair Ahmed | Technical Recruiter | Panzer Solutions LLC |50 Washington Street, 9th Floor, SONO Corporate Center, Norwalk CT 06854 USA
Email: zubair.ahmed@panzersols.com | Direct: 203-442-9692 OR at: 203 652 1444 Ext: 108 OR 651-433-7040*108
To view our Available Jobs: http://www.panzersolutions.com/job-opportunities

Quality Manager, Mahle, Inc. – Ft. Worth, TX

Would you like to take on assignments with a high level of responsibility?

  • Create and document robust Quality process
  • Lead MAHLE in process of ISO certification
  • Perform all Quality-related qualifications related to new product introduction
  • Manage Customer score cards
  • Initiate corrective actions in order to meet customer requirements
  • Handle customer complaint and manage via their systems

Impress us – with your professional and personal skills

  • Quality System background:  ISO 9000, TS 16949, APQP, PPAP
  • Strong problem-solving skills, root cause 8-D, pareto, fishbone
  • Ability to  handle customer communications in written and verbal form
  • Familiar with dimentional measuring instruments preferred
  • Bachelor’s degree in Engineering or similar analytical discipline required
  • Experience in an automotive or heave duty truck manufacturing facility preferred
  • Experience in system, process and product quality audits
  • ASQ Membership and Certificate preferred

Benefits

We offer you excellent opportunities for growth and development, tailored specifically for you.  We ensure this through regular meetings focused on feedback and a diverse training program.  We value outstanding performance. That’s why our goal is to work with you on a long-term basis.  We not only encourage you to reach your potential, we also offer performance-based pay and flexible working options for your different stages of life.  Go your path – with us.

Please send resumes and inquiries to Stephanie.Deloach@us.mahle.com
Stephanie DeLoach
MAHLE Behr Service America L.L.C.
(TSNO)
5020 Augusta Drive, Fort Worth, Texas 76106 USA
Phone: +1 817 740-3761, Fax: 817-626-8826
stephanie.deloach@us.mahle.com,

http://www.mahle-behr-service.com

QA- San Antonio TX – 6+ months

Hello,
Hope you doing well.

 

Please let me know if you are interested in this requirement.
If YES, Please send me your resume along with your contact information, If
Not please feel free to forward this requirement to someone you know who are
interested.

 

Job Title: QA Test Analyst 5
Location:  San Antonio, TX
Duration: 6 Months Contract with possibility of extension
Interview Process: Phone screen followed by face to face interview then final decision

 

JOB DESCRIPTION:
Must have Performance Testing experience!
Must have Performance Testing experience!
Will Halt the job Thursday Close of Business, meeting with manager Friday to discuss candidates.
Change & Release Management, Solution Manager Charm, QA Management

 

 10+ years of experience as a QA Analyst to include experience as a team lead
8+ years of experience with HP ALM
2+ years of Worksoft experience required!
Involved in Worksoft Certify 8.0 Automation tool with SAP’s Solution manager for Functional Testing SAP modules.
Supported approximately 8-12 subject matter experts during testing to document the issues they encountered in the defect management tool ALM.
Worked with release management for application maintenance releases and production defect fixes; performed smoke test.
Experienced with HP/Mercury Tools (QTP AND SELENIUM, Win Runner, Quality Center, Test Director and Load Runner) and Rational Suite (Test Manager, Robot, Requisite pro, Rational Rose, Clear Quest, Clear Case).
Bachelor of Engineering in Computer Science & Information Technology

 

Note: In case I am not available or for any escalations, you can reach my  manager Leon Parker  2036521444 ext 111 /leon.parker@panzerllc.com
===================================================================================================================================================
Warm Regards,
Raj Sandesh| Technical Recruiter
Panzer Solutions
50 Washington Street,
9th Floor, SONO Corporate Center Norwalk CT 06854
Raj.sandesh@panzersols.com
Direct: 2036521444 Ext 174 (OR) 203-442-9754
Fax: 2032861457
http://www.panzersolutions.com/reviews.
http://www.panzersolutions.com/jobopportunities

 

Senior Regulatory Affairs Specialist – Inogen, Richardson, TX

ABOUT INOGEN 

Inogen was founded in 2001 to improve quality of life and increase freedom and independence for oxygen therapy users. Inogen is innovation in oxygen therapy. The Inogen mission is to improve freedom and independence for oxygen therapy patients through innovative products and services. Inogen is a manufacturer and Accredited Homecare Provider.

Inogen is focused on quality care, continuous improvement, and outstanding customer satisfaction. We are a stable, USA based company dedicated to providing an exciting and rewarding career to our employees. We completed a successful Initial Public Offering on the NASDAQ in 2014 and have demonstrated substantial growth over the last five years. Our work environment is casual yet high performing, and we are looking for seriously talented, motivated, and fast-paced professionals to join our team.

JOB DESCRIPTION 

The Senior Regulatory Affairs (RA) Specialist has responsibility for ensuring organizational compliance with quality and regulatory standards for both product and company operations. The position is responsible for obtaining regulatory clearances/ approvals and overseeing a Quality Management System (QMS) that is in keeping with business objectives and government directives.

Key Competencies:

  • Assist in obtaining all necessary domestic and international regulatory registrations, product clearances/ approvals, certifications and in maintaining documentation needed to support ISO, FDA, and EU/ international compliance, allowing for the sale of Inogen products in US, EU, Canadian and other international markets, as determined by business objectives.
  • Compile, submit, and monitor reports and responses to regulatory authorities and related third-parties.
  • Support regulatory agency and third-party inspections and audits.
  • Maintain/ support the Internal Audit Program company-wide for a fully compliant Quality Management System (QMS) – including within its scope applicable accreditation and Home Medical Equipment (HME)/ Durable Medical Equipment (DME) compliance provisions.
  • Support the Supplier Auditor Program as a QMS Supplier Auditor, as required.
  • Provide company-wide Quality Management System (QMS) training and regulatory expertise, as needed.
  • Support the Corrective and Preventive Action (CAPA) program.
  • Participate in product development activities, including evaluating and advising personnel on regulatory impact throughout product lifecycle stages, ensuring that regulatory-specific (product and process) standards are understood, that a design control system is in place, that design validation activities are conducted, and that a Design History File (DHF) is maintained to support regulatory submissions.
  • Support Engineering efforts with review of technical/ regulatory standards for impact to development/ product.
  • Participate in transfer of approved product design to Manufacturing to meet market introduction and other key milestone target dates, ensuring that a Device Master Record (DMR) is in place (specifications, bill of materials, drawings, material specifications, labeling, etc.).
  • Participate in the development of manufacturing and inspection/ test procedures, including required validations for final product release.
  • Participate in change control activities, such as design changes, manufacturing improvements, new supplier introductions, cost reduction initiatives, etc., ensuring that regulatory standards are understood.
  • Support key business relationships by providing regulatory expertise specific to contract manufacturing and/or private label arrangements.
  • Manage post market surveillance (PMS) activities, including customer complaints/ adverse medical event reporting systems, risk files, etc.
  • Assist with the compilation of Clinical Evidence Reports, as needed.
  • Facilitate Kaizen initiatives to introduce improvements throughout the Quality Management System and/or serve as the Regulatory Affairs delegate for such forums, as needed.
  • Support Operations reporting and trending.
  • Mentor junior staff and manage consultants, as assigned.

 Do you possess these abilities?

  • Knowledge of ISO and FDA regulations required
  • Previous experience in Regulatory Affairs (specifically medical devices) and at least one (1) of the following: product development, manufacturing engineering, quality assurance, or production management required
  • Ability to facilitate external/ internal audits required
  • Attention to detail required
  • Excellent skills with database systems and Excel with capability to compile data from various sources to produce useful reports for trending and verifying process improvements required.
  • Knowledge of DMEPOS accreditation requirements preferred
  • Experience with DMEPOS/ CMS preferred
  • Familiarity with process improvement concepts (i.e. LEAN, Six Sigma, etc) preferred
  • ISO 13485:2016 Lead Auditor Certification and/or ASQ CQA, and/or ASQ CBA preferred

Requirements:

  • BS in Engineering, Biological Science or other technical discipline or equivalent
  • Five (5) years minimum experience in medical device manufacturing environment

WHY INOGEN Inogen is a dynamic company that is not only focused on quality care of patients, but is also committed to being a top employer.  Each of Inogen’ s offices have a casual culture that supports employees being responsible and developing professionals.

We offer competitive salaries and a robust benefit package:

  • Employee Stock Purchase Plan 401 (K) plan available for all employees Health, dental, vision insurance Flexible spending accounts and wellness discount program Life Insurance Long Term Disability Robust paid time off and 8 paid holidays Employee Assistance Program

See the Inogen Team in action:

https://www.youtube.com/watch?v=dKoTMeJf5J4

 

Inogen Where we go to work hard to positively impact people’s lives

 

Inogen is an equal opportunity employer.  We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. The EEO is the Law poster and its supplement are available here: http://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm; http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf.  The pay transparency policy is available here: http://www.dol.gov/ofccp/pdf/EO13665_PrescribedNondiscriminationPostingLanguage_JRFQA508c.pdf.

Inogen is committed to working with and providing reasonable accommodations to individuals with disabilities.  If you need a reasonable accommodation because of a disability for any part of the employment process, please send an e-mail to recruiting@inogen.net or call (972) 616-5668 and let us know the nature of your request and your contact information.

 

QA Test Analyst –San Antonio, TX–6 months

Contract with possibility of extension
Hiring Process: Phone screen followed by face to face interview then final decision

 

Must have Performance Testing experience!
Will Halt the job Thursday Close of Business, meeting with manager Friday to discuss candidates.
Change & Release Management, Solution Manager Charm, QA Management

 

10+ years of experience as a QA Analyst to include experience as a team lead
8+ years of experience with HP ALM
2+ years of Worksoft experience
Involved in Worksoft Certify 8.0 Automation tool with SAP’s Solution manager for Functional Testing SAP modules.
Supported approximately 8-12 subject matter experts during testing to document the issues they encountered in the defect management tool ALM.
Worked with release management for application maintenance releases and production defect fixes; performed smoke test.
Experienced with HP/Mercury Tools (QTP AND SELENIUM, Win Runner, Quality Center, Test Director and Load Runner) and Rational Suite (Test Manager, Robot, Requisite pro, Rational Rose, Clear Quest, Clear Case).
Bachelor of Engineering in Computer Science & Information Technology

 

—————————————————————————————————
Note: In case I am not available or for any escalations, you can reach my manager Leon Parker @ 203-652-1444*111 / leon.parker@panzersolutions.com

Thanks and Regards
Kiran Mayi| Technical Recruiter
Panzer Solutions LLC
50 Washington Street, 9th Floor,
SONO Corporate Center, Norwalk CT 06854
Tel: 203-652-1444*198 / Fax: 2032861457
Email: kiran.mayi@panzersols.com
http://www.panzersolutions.com/reviews

Exploring the FDA Refuse-To-Accept (RTA) Guidance for 510(k) Submissions – Webinar

Promoted by: ASQ-Dallas Food, Drug & Cosmetics SIG

Live Webinar on May 31, 2018 | 01:00 PM ET | 12:00 PM CT | 10:00 AM PT | Duration: 60 Min By: Angela Bazigos

REGISTER NOW

Are you contain necessary component or you complete all step of 510(k) submission to allow consume Center resources?

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Centers resources, the FDA has implemented procedures to ensure that 510Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.

The FDA has instigated a Refuse to Accept Policy and will no longer accept 510K submissions that do not meet a minimum threshold of acceptability. By doing so, the Center for Devices and Radiological Health, will be able to focus substantive review on submissions that are complete. It is expected that 510(K)s that are accepted under this new policy, will be reviewed more quickly.

Our expert Angela Bazigos help you to understand the various cause of refusion to accept 510(k) Submissions.

Why should you attend:

In this webinar, you will learn what the FDA expects for a 510K submission. By following the principles outlined in this webinar, you will minimize the risk of your submission being rejected and you will increase the potential for a speedy review and approval by the agency.

Session Highlights:

  • FDA’s Guidance on Refuse to Accept
  • Pre-Submission Interaction
  • 510(K) Refuse to Accept Policies and Procedures High Level
    • the 510(k) Checklist
    • FDA Review Clock
    • Notification of Acceptance Review Result
  • Refuse to Accept Principles – Details
  • Refuse to Accept Checklist – Details
  • Acceptance Review Checklist  Details
  • Traditional vs Non-Traditional 510(K)s

 

CLICK HERE TO REGISTER

Use “FDA40” to get $40 Off.
Attend in a Group and save upto 50%. Email us at support@pioneereducator.com for bulk orders.

Director, Quality & Continuous Improvement – Corpus Christi, TX

GENERAL DESCRIPTION:

This position will be responsible for building and leading a top-notch Quality and Continuous Improvement organization for a leading manufacturing company and will be a direct contributor to the formulation of the company’s business plan and strategic initiatives. The position will also be responsible for deploying Lean and Six Sigma improvement initiatives across the company. The position, which covers Quality, Continuous Improvement, and Lean functions for Product Development, Manufacturing, Quality, and Supplier Quality, etc. Is located in Corpus Christi, TX and reports to the company President.

DUTIES:

  • Build and manage a superior Quality and Continuous Improvement organization that is highly focused on its goals of achieving outstanding product and process Quality.
  • As part of the Senior Executive Team, assist in the definition of the company’s long-term business strategy and manage related Quality and Continuous Improvement strategic objectives.
  • Develop, implement, and manage the Quality and Continuous Improvement Team’s goals and objectives while building the company’s capabilities in Quality, Continuous Improvement, and Lean Methodologies.
  • Preserve high levels of customer satisfaction while supporting the balance of Quality with business objectives.
  • Integrate the use of Lean Six Sigma Tools and Methodologies into all business related processes and procedures.
  • Pursue the delivery of best-in-class products by developing top-notch quality strategies and performance metrics.
  • Lead cross-functional projects and initiatives to deliver process improvements, lean strategies, and best practices in the areas of lean manufacturing, six sigma, kaizen, etc.
  • Be recognized as a key Champion of Change throughout the company ensuring that process improvement activity is communicated, supported, and celebrated within the organization.
  • Collaborate closely with product development teams to improve the new product development stage-gate process by strengthening the procedures and processes used for CTQ development, testing, design review, risk analysis, and document control.
  • Select and manage the implementation of a Supplier Quality Management System that will aid in the development of a world-class supply chain.
  • Cultivate a customer related Quality environment that is acceptable to change and will advance Continuous Improvement in all processes using Lean methods.
  • Lead change management activities that will promote the company’s transition to a Lean thinking organization.
  • To achieve Quality, Lean Transformation, and Customer Service objectives, define and execute associated company goals, business metrics, and improvement strategies.
  • Ensure product and process quality is in compliance with government and industry standards & codes.
  • Implement Continuous Improvement corrective actions to better customer satisfaction and brand loyalty by analyzing customer and field performance data for possible areas of improvement.
  • Improve and enhance all company processes through the use of Lean Methods like Gemba Walks, 6S, SQDC Boards, Kaizen Events, etc.
  • Improve and enhance all company processes through the use of quality tools like SPC, Standard Work, Control Plans, etc.
  • Mentor, coach, and train the organization on the use and implementation of key Quality Tools.
  • Mentor, coach, and train the organization on the use and implementation of Lean Methods and Tools.

QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:

  • At least ten years of progressive experience and accomplishments in Quality/ Continuous Improvement/ Lean Methodologies with at least five years of managerial experience.
  • Bachelor’s degree in a technical discipline.
  • Solid background with multi-site manufacturing operations.
  • Sound business and financial acumen with motivation to maximize company profits.
  • Strong executive presence.
  • Demonstrated ability to effectively partner with the business leadership and influence the strategic and tactical business interests of the organization.
  • Demonstrable experience in culture development, change management, and process improvement with a proven ability to analyze business needs and make recommendations for improvements as required.
  • Experience in an area outside of Quality like R&D, Manufacturing, Product Development, Process Engineering, etc.
  • Superior communicator with outstanding interpersonal skills and the ability to build relationships across all organizational levels.
  • Ability to influence team dynamics in a cross-functional environment regarding Quality, Continuous Improvement, and Lean goals and objectives.
  • Solid relationship building and project management skills with the ability to work effectively with and gain acceptance for company initiatives throughout the organization.
  • CQE and/or CQM.
  • Experience directing Lean Kaizen activities using Lean Tools like Gemba Walks, 5S, SQDC Boards, SMED, TPM, Kanban, Standard Work, Value Stream Mapping, etc.
  • Black Belt in Lean and/or Six Sigma.
  • ISO/QS/TS type Quality System experience.
  • Supplier Quality Management System experience.
  • An understanding of Supply Chain Logistics.
  • Experience with PCB assembly.
  • Solid understanding of statistical methods and their application to product/ process engineering.
  • Excellent project management background with a history of implementing process improvements.
  • Experience implementing a Lean System.
  • Ability to travel 25% to 30%.

 

For additional information, please contact:
John Zee
President, Zee Executive Search (BSEE – MBA)
972-953-6101
zee@airmail.net