Sr Manager, Quality Engineering

Company: Integra LifeSciences
Location: Boston
Posted on: July 23, 2021

Job Description:

Integra LifeSciences is a global leader in regenerative technologies and neurosurgical solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care.

Founded in 1989, Integra develops, manufactures, sells and supplies best-in-class products to regenerate tissue, remove brain tumors, prevent infection and much more. And over the last three decades, we’ve evolved into one of the world’s leading global medical technology companies with more than 4,000 dedicated employees who deliver innovative medical technology solutions.

But that’s just the beginning. Integra is growing at an unprecedented rate. We’re at a moment in time where the experience you’ll gain is more robust than the experience you bring. And we’re out to invest in your future because it’s the best way to maximize ours.

At Integra, we firmly believe our people are our greatest asset and the foundation of our success. Our comprehensive Global Total Rewards program provides competitive compensation and benefits designed to keep our people healthy, motivated and engaged. Investing in our people through these programs is possible because of Integra’s ongoing commitment to our values and our shared success.

Integra’s health as a company begins with the well-being of our people. Benefit programs vary by country, whether provided through company-sponsored insurance and programs, through statutory government programs, or a combination of both.

Regardless of geographic location, our commitment is to offer the following, whenever possible:

• Benefit plans that meet all local statutory requirements
• A range of programs that reflect typical local market practices
• An opportunity for employees to tailor benefits to their specific needs
• Benefits that balance employee’s short-term and long-term needs

Click HERE for more information regarding our benefits and total rewards program

• Management of Quality Engineering areas of responsibility, including:
  • Complaint Investigations/ AER/Recall Support (HIA/HHE)
  • Control of NC Product/MRB/Product disposition approvals
  • Product Holds – Initiation and Release
  • CAPA support of investigations
  • Risk Management support
  • Change Control (design & process) - DCR/ECR approvals
  • Inspection Plan Development
  • Equipment Management
  • EU MDR Support
  • NPI Support
• Management and mentoring of Quality Engineering personnel.
• Quality Engineering representative during Management Reviews and audits (internal and external).
• Other Quality Engineering areas as assigned by Director of QA Operations.

• Bachelor’s degree in Quality Assurance or Engineering or related discipline.
• Five to ten (5-10) years’ of experience in Quality Engineering in the Medical Device Industry.
• Experience in personnel management and mentoring.
• Demonstrated experience in successfully leading a team.
• Experience in project management.
• Experience with statistical techniques.
• Working knowledge of QA Engineering related QMS elements including Design Controls, Production and Process Controls (including Process Validation), Control of Nonconforming Product, Facilities/Environmental Controls, Labeling and Packaging Controls, Handling, Storage, Packaging and Distribution of Product, Inspection and Test, Test Method Validations.
• Experience with CAPA processes including investigational techniques.
• Experience with Risk Management regulations and application (ISO14971).
• Working knowledge of medical device regulations (including FDA QSRs, ISO13485).
• Strong technical aptitude (i.e., able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).
• Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
• Ability to communicate effectively (both written and oral) using English (or local language).
• Ability to influence positive change effectively.
• Exceptional conflict-resolution skills.
• Experience with development and implementation of quality system procedures.
• Experience with tissue products preferred.
• Experience with Cleanroom environment and requirements preferred.
• Certified Quality Engineer (e.g., ASQ CQE) preferred.

Keywords: Integra LifeSciences, Boston , Sr Manager, Quality Engineering, Other , Boston, Massachusetts