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Senior Quality Engineer External Manufacturing

4 months ago

Boston, Massachusetts, United States Integra LifeSciences Full time

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

SUMMARY OF POSITION:

This position is for a Sr. Quality Engineer, External Manufacturing with hands on experience and proven success in providing quality leadership and technical support to ensure robust quality systems at the external manufacturing sites. This position will have the oversight in the selection and qualification of the ExM sites.

The candidate will work closely with commercial manufacturing team members, and ExM/Contract manufacturing leadership and maintains knowledge of current GMP expectations to define and drive Commercial QA objectives, strategies, and solutions to achieve these goals. The position will also have some oversight of managing supplier quality for the direct material suppliers.

The candidate will have demonstrated proficient experience with quality engineering concepts, including but not limited to design control, risk management, supplier quality, and continuous improvement. The candidate must also demonstrate consistent good decision-making skills and will have the experience to proactively identify and lead business development opportunities or address issues outside of their core responsibilities with minimal supervision. Additionally, the candidate will possess the critical behavioral skills integral to developing and strengthening productive relationships/partnerships.

  • Support the development and manufacturing of medical devices in conformance with the Quality System Regulation, ISO 13485, Medical Device Directive, ISO 14971, IEC 60601 and other regulatory standards.
  • Lead the identification and resolution of quality issues and complaints, including facilitation of investigation process and development of robust CAPA plans.
  • Perform Quality audits as required.
  • Review and approve quality systems documentation, including product disposition, manufacturing instructions, change controls, and process validation documentation.
  • Monitor quality performance of the ExM sites through the development of key performance indicators
  • Analyze data to identify risks and drive implementation of mitigation plans.
  • Build relationships with internal and external partners and influence external manufacturers to continuously improve processes and procedures.
  • Collaborate with External Manufacturers during regulatory audits and inspections.
  • Support Supplier Quality projects and issues as needed
  • Provide oversight during tech transfer and new product introduction activities.
  • Have an oversight of quality relationship to manage change notifications, respond to SCARs, establish quality agreements, and maintain strong relationship with Private Label Partners.
  • Provide guidance and interpretation for industry related regulations within the framework of organizational product and sustaining development processes.
  • Utilize coaching and facilitating skills with program shareholders to ensure proper project management, expectation setting, and best practices are utilized.
  • Other duties as assigned.
  • B.S. in Engineering or associated scientific discipline.
  • Minimum 5 years Medical Devices or Pharmaceutical experience in Quality or R&D Engineering position.
  • DMAIC experience - preferred
  • Certified Quality Engineer (CQE) - preferred
  • Certified Quality Auditor (CQA) - preferred
  • Proficient with Minitab.
  • Coaching and mentoring skills.
  • Proven ability to directly lead and/or co-lead multiple tasks and projects.
  • Strong understanding of industry expectations in the areas such as voice of customer, specification development, risk management, design verification and validation, stability studies, sterilization validation, biocompatibility, transportation testing, etc.
  • Working knowledge of quality engineering principles, supplier management, and manufacturing operations within a regulated industry (preferably medical devices).
  • Proficient with utilization of quality tools (Six Sigma, Statistical Techniques, Sampling Principles, Risk Assessment, Root Cause Analysis, FMEA, FTA, DOE, etc.).
  • Working knowledge of electro-mechanical devices, software validation methods, and/or plastics related manufacturing processes (ie extrusion, injection molding, RF welding, etc.) is preferred.
  • Ability to interpret mechanical drawings.
  • Familiar with gage and inspection techniques.
  • Strong collaboration, negotiating, and conflict resolution skills.
  • Fluid verbal and written communication skills.
  • Travel up to 30%

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices:

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