Blog

Quality Manager – Atron Group – Dallas, TX

ATRON Group is looking for a  Quality Manager to join its top management team.

Our Quality Manager is directly responsible to provide vision, leadership and management of all organizational aspects of quality performance, process effectiveness, improvement and product conformity.

This includes oversight of quality management systems, competency training, organizational cadence & rhythm, enterprise. AS9100/D certification and its maintenance, customer issue investigations and compliance with regulatory and industry requirement.

Key Accountabilities:

  • Drive business philosophies, perspectives, initiatives, and leadership expectations to enable company and culture transformation.
  • Understand and execute Annual Strategic Operating Plan in a manner that results in exacting results, sales and profitability growth at or above the agreed budget and expectations.
  • Standardize Quality Performance Reporting.
  • Align Quality to Balanced Score Card.
  • Standardize performance training, competency and accountability across the organization
  • Establish and reinforce a distinct, enterprise-wide QA/QC functional organization.
  • Drive excellence by attracting, motivating, aligning, developing, and training the talent required for industry leading quality management team.
  • Optimize QC product and process oversight, bringing clarity to ambiguous requirements.
  • Maintain AS9100/D certification and audit program.
  • Maintain UL file and procedure compliance.
  • Maintain record retention program.
  • Facilitate effective management review activities including planning, alignment and high impact outcomes.
  • Support customer on boarding, product launch and change control to ensure seamless quality for our customers.
  • Provide business insight and make recommendations based on data and observations.

Key Business Interfaces:

Reports to President/CEO. Is a member of “Top Management” which includes, leaders of Quality, Engineering, Manufacturing, Materials, Sales, Finance & Administration departments.

 

Key transformational 2019 initiatives:

  • NADCAP certification.
  • Establish & support “Next up” Leadership Development coaching, training and competency program.
  • Support and Improve RMA/MRB/Corrective Action/Reporting cycle, “keep it moving” initiative.

 

Position Requirements:

  • Bachelors degree required,  advanced degree preferred
  • 10,000+ hours experience in a similar role.
  • Experience with manufacturing companies; Electrical/electronics controls and assembly experience not required but preferred.
  • Experience driving quality within multi brand manufacturing operations.
  • Strong interpersonal and communication skills.
  • Ability to multitask and quickly change course as required by company or market forces.
  • Experience working in a matrix organization.
  • Ability to travel up to 5% including international travel.

Key Competencies:

  • Strategic Thinking – Anticipate needs and articulate a clear and credible strategic direction for future work.
  • Change Agent – Be at the forefront of change, embrace it and encourage others to do the same.
  • Leadership – Provides others with the knowledge, information and authority they need to be engaged and successful.
  • Do what you say – Understand the power of commitment and finishing well to building organizational trust.
  • Business acumen – Understand the competitive landscape and the processes, functions and metrics of the business.
  • Action-orientation – Take action without being prompted and commit to achieving challenging goals.
  • Setting Direction – Provide others with a clear direction on task and goal expectation and aligning them with business goals.
  • Solutions orientation – Seek out new approaches to transform the business and contribute creative and unique ideas to work products.
  • Customer orientation – Provide the best of class quality of process, products and services to the customers with maturity and professionalism.
  • Continuous Improvement – Find ways to enhance the quality or efficiency of processes, products and services on an ongoing basis

Email your resume with a brief but well organized letter addressing how your talents, experience and education conforms to our requirements above.

Please include “ASQ Quality Leader” in the subject line when emailing to hr@atrongroup.com

Professional Development Meeting – 2018 October 25th

Director of Quality – Amphenol FSI – Allen, Tx

DIRECTOR OF QUALITY

Amphenol Fiber Systems International (AFSI) is a full service fiber optic company specializing in the fabrication and 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.

GENERAL DESCRIPTION:  The Director of Quality 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. The Director of Quality is also responsible for ensuring compliance and for implementing and driving a Zero Defect program.  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:

  • Work seamlessly with Operations to ensure quality product is shipped on time
  • Implement a Zero Defect program and drive cultural awareness/adoption across division
  • 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
  • Responsible for maintaining compliance for Defense Logistics Agency (DLA) Qualified Products List (QPL)
  • 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 travel may be required

Required Knowledge, Skills, and Abilities:

  • Ability to execute procedures with a great deal of detail
  • Advanced project management experience; detail oriented
  • 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 and AS9100
  • 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
  • 5 years’ or more experience in quality management, manufacturing quality engineering, process engineering or product engineering
  • Working knowledge of advanced quality tools such as Zero Defect Planning, Advanced Product Quality Planning (APQP) and 5 Why root cause analysis/corrective action
  • Experience with Supplier Quality Engineering
  • S. person as defined in ITAR, 22CFR 1120.15 (U.S. Citizenship or Resident Alien Status)

Amphenol Fiber Systems International is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, marital status, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.

 

Apply online with the following link:

http://www.fibersystems.com/employment/

 

Website: www.amphenol-fsi.com

Risk and Regulatory Compliance – 2018 Midwest FDC Conference

Risk and Regulatory Compliance

Don’t miss the 2018 Midwest FDC Conference

October 3, 2018 at Wojcik Conference Center – Harper College

Palatine, Illinois

Regulatory authorities have embraced science-based risk management.  As the supply chain becomes more complex, risk awareness and quality aspects in general become more important.
All countries involved in regulated industries should have quality processes for sourcing of materials, manufacturing, packaging, testing, storage, and distribution.  These quality processes provide rationale to understand risk, as well as to mitigate it through appropriate and robust controls.

Members:  $100  Non-Members:  $120

Developing a Strategic Approach to FDA Compliance for Computer System Validation – Webinar

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

Live Webinar on Oct 10, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Carolyn Troiano

REGISTER NOW

You will learn how to take a strategic approach to validating computer systems that are regulated by FDA in a way that will be cost effective and efficient. The webinar will go through the System Development Life Cycle (SDLC) methodology in detail, and we will demonstrate how the SDLC supports Computer System Validation (CSV).

This webinar will help you understand in detail Computer System Validation (CSV) and how to apply the System Development Life Cycle (SDLC) Methodology when validating computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement. We will discuss the phases within the SDLC, and how these forms the basis for any CSV project. The importance of the sequence of steps will also be covered.

Why Should You Attend

An FDA inspection or audit is something to take very seriously, and it’s important to have all computer systems that are regulated by FDA fully validated. In this FDA Compliance training, you will learn how to validate computer systems in compliance with FDA’s guidelines and also how to maintain them in a validated state. This will provide you with a level of certainty that you will be able to respond to FDA questions and provide the documentation necessary to defend your approach and body of work.

Learning Objectives:

  • Learn about industry best practices related to compliance and computer system validation
  • Learn about strategies for reducing the cost and complexity of compliance with FDA regulations
  • Understand how the System Development Life Cycle (SDLC) methodology supports the computer system validation process
  • ….. and more

Session Highlights:

  • Computer System Validation (CSV) and the System Development Life Cycle (SDLC) Methodology
  • Good “Variable” Practice (GxP) (Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP))
  • Validation Strategy that will take into account the system risk assessment process
  • ….. and more

CLICK HERE TO REGISTER

Use Coupon Code “FDA25” to get $25 Off.
Attend in a Group and save upto 50%. Email us at support@pioneereducator.com for bulk orders.

FDA’s Expectations from Supplier Management for GMP: Quality Agreements and More – Webinar

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

Live Webinar on Oct 12, 2018 | 1:00 PM ET | 12:00 PM CT | 10:00 AM PT | 60 Minutes | By: Danielle DeLucy

REGISTER NOW

The FDA requires that manufacturers of pharmaceutical products have a documented process to assess its suppliers and contract manufacturers, that they have implemented that process, and that the process is effective. This training program will explore how having an effective supplier relationship management program will result in streamlining the supply chain, ensuring a more consistent level of quality components, materials and components, and be more cost effective to the manufacturer.

Why Should You Attend

Failure to adequately assess and control your supplier/subcontractor pool can result in dire consequences for an organization. Assessing and approving your suppliers before placing the first order with them will eliminate many headaches for a medical device manufacturer.

Many organizations conduct supplier audits because they are required to do so by their customers or a regulatory agency. Others conduct the audits because they have been led to believe that it’s a good tool for comparing various suppliers against an arbitrary list of criteria.

While all of these reasons have varying degrees of validity, none of them articulate the best reason for having a robust supplier audit program. A good supplier audit program should allow an organization to assess and periodically re-affirm the ability of key suppliers to provide conforming product consistently, reliably and on-time. It should be one of the most important initiatives toward fulfilling the goal of having a sustainable supply chain.

Learning Objectives:

  • Understanding the FDA’s requirements for medical device supplier assessment and approvals
  • Learning “who” are considered to be suppliers
  • Knowing how to structure a supplier quality agreement
  • Selecting the potential methods for evaluating and assessing suppliers

Areas Covered in the Webinar:

  • Regulatory requirements for supplier qualification
  • Responsibilities of manufactures and suppliers
  • Best practices for supplier selection, qualification and management
  • What are the FDA’s expectations in regards to quality agreements?
  • What is meant by the title owner, contractor, adulterated drug, and the term manufacturing within the guidance?
  • Best practices for a good quality agreement
  • Supplier audits
  • Documentation requirements and audit trails

CLICK HERE TO REGISTER

Use Coupon Code “FDA25” to get $25 Off.
Attend in a Group and save upto 50%. Email us at support@pioneereducator.com for bulk orders.

Project – ISO Auditor – Johns Manville – Cleburne, Texas

Experienced ISO Auditor – Project

Our company is transitioning between ISO standards and we currently only have one qualified internal auditor.

To finish our internal audits we need an additional “independent” auditor.

We are hoping to conduct the audits on 10/3 & 10/4/2015.

If interested, contact James Thornton at Insulation Systems.

 

 

James Thornton
Quality Manager / Insulation Systems
Johns Manville | A Berkshire Hathaway Company
200 W. Industrial Blvd.
Cleburne, TX, 76033
W: +1-817-556-6618
M: +1-817-357-7965
Email: james.thornton@jm.com