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Manager - Quality Engineering-Design

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Job Type
Direct Hire
Bachelor of Science
May 09, 2017
Job ID
Manager - Quality Engineering-Design

Quality Engineering Manager
We are looking for a dynamic and inspiring Quality Engineering Manager to join and support our growing corporate Design Quality team.  We are looking for an experienced manager to continue our development and enhancement of efficient, best in class, systems supporting new product development and design controls.  You’ll be joining a talented team of motivated professionals at a global medical device designer and manufacturer, dedicated to supporting continued business growth and expansion initiatives.  This is an opportunity to use your background and experience to leave a lasting mark on a fast-paced, growth-oriented, private organization.  Candidates must be committed to excellence in all areas and take pride in providing elegant and scalable solutions to complex problems supporting quality and patient safety throughout the companies various business interests.

About You: 
  • Motivated, driven to learn, and thrive in a dynamic and fast-paced environment;
  • Have a track record of employee/team development and engagement in design control and risk management processes;
  • Dedicated to seeking out opportunity for the continuous improvement of processes and programs, striving for efficiency while maintaining high quality and compliant outputs;
  • Enjoy a working in and promoting a collaborative, team-based atmosphere in an open and modern work environment;
  • Have a keen sense of what “good” looks like and are adept at coaching team members & business partners towards it.
Some More Details:
  • Hands-on experience managing teams supporting the quality aspects of new product design and risk management programs.
  • Intimate working knowledge of relevant regulations and standards (i.e. 21 CFR 820, ISO 13485:2016, European MDR, ISO 14971:2012, etc.);
  • Full understanding of state of the art / best practice and requirements governing the medical device industry related to design controls and risk management programs;
About Us

We are a global medical device company and a leader in new product development, commercialization, and medical education. As members of the Pre-Production Quality team, you will be the front-line in ensuring compliant product designs, patient safety, and supporting the organization in its mission of helping surgeons treat their patients better.  
Main Objective:
Responsible for leading quality engineering team for design, development transfer and post-market surveillance of FDA Class I and II, EU Class I, IIa, IIb and III medical devices in the achievement of company goals
Essential Duties and Responsibilities:
  1. Manages Quality Engineering Supervisors, Quality Engineers and Quality Assurance Technicians assigned to design activities to provide timely and efficient flow of services and projects;
  2. Maintains a leading edge understanding of the quality processes required in design and post-market performance components in order to find new and novel opportunities to improve product quality and reduce cost;
  3. Drives review of the effectiveness of the quality management system’ design and effectively implements enhancements and improvements as necessary to ensure maintenance of state-of-the-art processes and compliance to pertinent international standards and regulatory requirement, e.g., ISO 13484, 21 CFR 820, European MDR, etc.;
  4. Ensures effective implementation of reference standards in the execution of design-related activities, e.g., ISO 14971, IEC 62366, etc.;
  5. Fosters consistent quality input and partners with design engineering to support new product development and release processes;
  6. Provides Quality Engineering project oversight and management, including initiating and leading cross-functional teams;
  7. Generates and oversees the development quality timelines for new product introduction;
  8. Oversees timely and thorough investigation, root-cause analysis, completion, and effectiveness review of product design-related corrective and preventive actions (CAPA);
  9. Leads hiring and developing the quality engineering team by actively coaching and providing career development assistance to team members;
  10. Develops future leaders by effective selection, mentorship, and development activities;
  11. Reports progress and status of projects on a timely basis with emphasis on reporting results to upper management.

Education and Experience:
Bachelor of Science Degree in Engineering
Minimum 10 years Medical Device Manufacturing experience with a minimum of 3 years supervisory or management experience.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
  • Working knowledge of ISO and FDA quality requirements.
  • Manufacturing process knowledge.
  • Technical knowledge in development methodologies, design quality analysis, and project implementation.
  • Proficiency in assessing manufacturing quality requirements of new product ideas