-
Manager, Quality Assurance/Compliance
- Integra LifeSciences (Mansfield, MA)
-
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.
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.
Integra - Employer Branding from Integra LifeSciences on Vimeo (https://player.vimeo.com/video/265760526)
-
Recent Jobs
-
Manager, Quality Assurance/Compliance
- Integra LifeSciences (Mansfield, MA)