Job Information
Integra LifeSciences Manager, Quality Assurance/Compliance in Mansfield, Massachusetts
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.
Oversees the Quality Management System (QMS) processes and activities at the site.
Manages the Quality Assurance/Compliance teams to build and maintain an effective, competent, and efficient workforce for Quality Compliance activities.
Establishes and manages the Quality Assurance/Compliance budget to achieve organizational goals.
Drives the development and improvement of new processes, implementation of standards, and Quality Plans in support of the organization’s Quality 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 Control and Quality Records processes and personnel.
Management of Complaint Investigations for applicable Mansfield products.
Management of Internal Audit Program and audit team.
Management of Non-conformance (NC) process, including coordination of Material Review Board (MRB).
This role requires experience in the Front Room as an audit stream Lead for external Regulatory body (ex.- FDA, BSAI, etc.) audits and inspections.
Management of Training Program and records management.
Quality Management Review (QMR) Coordination and preparation.
Quality Plan project management to ensure timely completion.
Deputy site Quality Management Representative in absence of Director of Quality Operations.
Lead for external audit support including preparation and coordination of Backroom personnel and activities.
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.
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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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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