Changing lives. Building Careers.
 

Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Quality Compliance Manager will have a key leadership role ensuring overall site QMS compliance. Additionally, they will manage QMS systems, processes and personnel, including at a minimum, Document Control, Internal Audits, CAPA, Change Controls and training.  Will serve as alternate Quality Management Representative for the site with responsibilities including Quality Management Review preparation, Audit/inspection Backroom leadership and site Quality Leadership Team coordination. Works closely with all functional leaders to ensure on-going compliance and improvement.

Essential Duties and Responsibilities

To perform this job successfully, an individual must be able to oversee/perform each essential duty satisfactorily. Other duties may be assigned.

Management of Document Control/Quality Records processes and personnel.Management of Internal Audit Program and Audit Team.Management of central CAPA process, including coordination of CAPA Review Board (CRB).Management of site Training Program to ensure compliance.Quality Management Review coordination and preparation.Quality Plan project management to ensure timely completion.Alternate site Quality Management Representative in absence of QA Director.Backroom Leader during site audit/inspections. Alternate Front Room Leader.Other QA/Compliance activities as assigned by Director of QA Operations

Desired Minimum Qualifications

Education & Experience:

Bachelor's degree in quality assurance or related discipline with 3+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience in QA/Compliance within Medical Device Industry. OR  Master degree in Quality Assurance or related discipline with 0-2 years of experience leading a team or equivalent education and years of management experience in QA/Compliance within Medical Device Industry.

Extensive experience with development and implementation of quality management systems.Expert knowledge of medical device regulations (including FDA QSRs. ISO13485).Experience with developing or improving Document Control and Records Control processes.Experience with Training Program development/implementation.Experience conducting QMS/Quality training.Audit experience and certified Auditor.Experience in personnel management and mentoring.Demonstrated experience in successfully leading a team.Experience in project management.Ability to interface with top organizational leadership in an effective manner.Ability to communicate effectively (both written and verbal).Ability to influence positive change across the organizationExceptional conflict resolution skills.

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.

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