Massachusetts Green Jobs

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Oversees the QMS processes and activities at the site.

• Manages the Quality Compliance teams to build and maintain an effective workforce for Quality Compliance activities.

• Establishes and manages the Quality Compliance budget to achieve organizational goals.

• Drives the development of new processes, standards, or plans in support of the organization’s strategies.

• Prioritizes the completion of activities and projects to meet business needs.

• Ensures ongoing site compliance to documented processes, current Good Manufacturing Practices, and applicable regulations / standards.

• Management of Document-Change Control/Quality Records processes and personnel.

• Management of Internal Audit Program and audit team.

• Management of CAPA process, including coordination of CAPA Review Board (CRB).

• This role requires experience in the front room of external audits, and preferably experience with FDA inspections.

• This role will manage the CAPA program as well as be the site Quality reviewer and approver for CAPAs, including any addressing FDA 483 observations.

• Management of Training Program and records management.

• Quality Management Review Coordination and preparation.

• Quality Plan project management to ensure timely completion.

• Alternate site Quality Management Representative in absence of Director of QA Operations.

• Lead for external audit support including preparation and coordination of Backroom personnel and activities.

• Front room Lead for external audits.

• Actively participates in cross-functional Site Quality Leadership Team.

• Leads or supports quality initiatives/projects as assigned by Director, Quality Operations.

• Operates effectively with minimal supervision.

• Other activities as assigned.

DESIRED MINIMUM QUALIFICATIONS:

• Bachelor’s degree in quality, Regulatory, Biology or similar life sciences area, with 8+ years' experience in QA/Compliance with the medical device or similar industry.

• Or master’s degree with 5+ years’ applicable experience.

• Or Doctoral degree with 3+ years’ applicable experience.

• 5+ years’ supervisory experience managing a team.

• Expert knowledge of global medical device regulations.

• Expert knowledge and application experience in all aspects of Quality Management System in alignment with applicable global medical device regulations.

• Experience with External Regulatory Agency audits (e.g., Notified Bodies and FDA).

• Experience as a Front room Lead during external audits.

• Experience with development and implementation of quality management systems.

• Exceptional quality system and regulatory documentation writing and editing skills (e.g., CAPA records, audit NC responses).

• Expert knowledge and direct experience with developing, improving and managing Document/Change Control and Records Control processes.

• Expert knowledge and direct experience with CAPA processes and records, including investigational techniques and CAPA boards.

• Expert knowledge and direct experience with Training program development/implementation.

• Experience developing and conducting QMS/Quality training.

• Working knowledge of medical device Risk Management regulations and application.

• Expert knowledge and direct experience with leading an internal audit program and conducting audits. Certified Quality Auditor is a plus.

• Experience in project management.

• Ability to interface with top organizational leadership in an effective manner.

• Ability to communicate effectively (both written and oral) using English.

• Ability to influence positive change across organization.

• Good 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.

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:

EEO Is the Law (https://www.eeoc.gov/laws/index.cfm) | EOE including Disability/Protected Veterans (https://www.eeoc.gov/eeoc/publications/ada_veterans_employers.cfm)

Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA (https://www.eeoc.gov/eeoc/publications/fs-ada.cfm) . If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com or call us at 855-936-2666.

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