Amphenol FSI: Quality Manufacturing Engineer

Position requires candidates to be U.S. person as defined in ITAR, 22CFR 120.15 (U.S. Citizenship or Resident Alien Status)

Amphenol Fiber Systems International (AFSI) is a full service fiber optic company specializing in the fabrication of manufacture of fiber optic connectivity products and systems.  Our commitment to technical excellence makes us an industry leader in proficing sophisticated products and professional technical assistance in the fiber optic industry.  AFSI, located in Allen, Texas, has and will continue to base its strategy on technical and application support, quality assurance, product performance and value.

The Quality Manufacturing Engineer is responsible for understanding and interpreting all customer requirements to the Organization’s operations, and ensuring that the organization manufacturers product that meets or exceeds customers’ expectations. Position requires breadth of experience across multiple programs, products and customers to determine the right level of actions to improve / maintain the customer experience in all situations.

 Essential Functions:

  • Review customer drawings, specifications and contracts; interpret customer requirements and flow them down to the appropriate functions in the organization
  • Primarily responsible for understanding all customer requirements and communicating them during bid and contract reviews
  • Conduct FAI review and assessment
  • Conduct drawing reviews; audit Organization’s production drawings against customer drawings and requirements
  • Coordinate failure analysis; ensure true root cause identification and appropriate correct actions
  • Manage coordination of improvements; standardizing workmanship across the organization
  • Conduct internal quality audits in accordance with internal processes
  • Conduct customer quality audits to include design review
  • Work closely with Product Line Managers on new product introductions and ensuring customer expectations/requirements are met; assist in auditing Qualification Test Matrix against customer requirements
  • Manage documentation organization
  • Facilitate customer training
  • Some minimal travel may be required

Required Knowledge, Skills, and Abilities:

  • Proactive with desire to improve organization performance
  • Familiarity with software development, testing, introduction and upgrades
  • Ability to establish rapport with and elicit cooperation from people at all levels of an organization
  • Strong analytical and organizational skills
  • Strong oral and written communication skills, with the ability to influence & negotiate at all levels
  • Ability to make decisions and excel in situations characterized by uncertainty
  • Familiarity with ISO9000 desired
  • Strong project management skillset; detail oriented
  • Proficient in Microsoft Office (Word, Excel, PowerPoint)
  • Strong understanding of best practices in customer service

 Required Education and Experience:

  • Bachelor’s degree in Mechanical Engineering or related field
  • 2 -5 years’ experience in manufacturing quality engineering, process engineering or product engineering
  • Zero Defect Planning experience
  • Advanced Product Quality Planning (APQP) experience
  • 5 Why root cause analysis experience
  • S. person as defined in ITAR, 22CFR 120.15 (U.S. Citizenship or Resident Alien Status)

 

To apply for this position, please follow this link to complete the application process.  http://www.fibersystems.com/employment/

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.

 

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