Site Quality Manager

Integra LifeSciences is a global medical technology leader in neurosurgery and regenerative medicine driven by our purpose of restoring patients’ lives. The company offers a broad portfolio of products and innovative solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Its regenerative tissue technologies include products that address soft tissue, peripheral nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery.

Founded in 1989 by Richard E. Caruso, the company is headquartered in Princeton, New Jersey. Today, Integra LifeSciences has grown immensely, with more than 4200 employees worldwide as well as offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas.

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.

The Site Quality Manager is directly responsible for establishing quality policies, strategies and objectives for the company in collaboration senior leadership. They will work cross-functionally with Operations, Regulatory, R&D, Sales, Training and Marketing to assure all operations of the company comply with applicable QSR, ISO and FDA regulations.

Under general direction and in accordance with all applicable federal, state and local laws/regulations and Corporate procedures and guidelines, this position:

• Plans and directs resources and activities of the quality functions. Manages subordinates in areas of quality and is responsible for the overall direction, coordination and evaluation of quality matters.
• Creates long-range quality plans for the organization focusing on Quality System Strategies and establishing systems to ensure Life Cycle Management of products.
• Assures the implementation of policies and strategies for systems to assure compliance with regulations and industry standards.
• Responsible for communicating quality and business related issues or opportunities to next management level.
• Provide instruction and training to associates on requirements and best practices Quality System Processes
• Leadership role with the CAPA/Data Review Board to achieve quality goals.
• Ensure Quality System process execution, accountability, and due diligence. Ensure that trends are analyzed and that CAPAs and NCRs are initiated and completed as required.
• Report on a monthly and quarterly basis against established measures.

• Provides updates to company, franchise management, and corporate quality regarding compliance status and performance of the companies within the operating group relating to quality.
• Other responsibilities as required or assigned by manager.

Education and Experience:

• Bachelor’s degree in Engineering, physical or biological sciences, or mathematics
• At least 10 years of experience in medical device manufacturing or equivalent, with 5 years management experience
• Experience working with regulatory authorities and certification bodies
• Fluent in Hebrew and English

Preferred:

• Master’s degree in engineering, physical or biological sciences, or mathematics

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.