Integra LifeSciences Corporation
Location
Columbia, MD | United States
Job description
Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for surgeons, so they can concentrate on providing the best patient care. Integra offers innovative solutions in orthopedic extremity surgery, neurosurgery, reconstructive and general surgery, and regenerative wound care.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has more than 4,000 employees worldwide. Integra’s common stock is listed on The NASDAQ Stock Market under the symbol “IART.”
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.
SUMMARY
The Senior Quality Manager is responsible for the efficient and compliant functioning of the Quality Management System (QMS) processes and maintenance of the Medical Device Quality Management System and quality procedures in accordance with FDA 21 CFR Part 820, ISO 13485, MDSAP, CMDR, MDD, MDR and state and local regulations, and ILS-ACell policies and procedures. This role will lead the Quality Compliance team and is responsible for the site NC, CAPA and Complaint programs, Quality Control, Quality Assurance, Quality Engineering, Document Control, Records management, Quality Metrics and Internal Audit Program. This position will support external audits in the capacity of front room lead and provide backroom leadership. The Senior Quality Manager is responsible for all Quality staff and for ensuring that all measures are taken to maintain full compliance with applicable regulations and standards. The Senior Quality Manager is the Site’s Management Representative and Person Responsible for Regulatory Compliance (PRRC).
RESPONSIBILITIES
Direct all activities, functions, and personnel in the following areas:
Quality Engineering
Quality Assurance
Quality Control
Quality Laboratory
Complaints/MDRs investigation and approval
CAPA/NCMR/MRB/Deviations
Document Control
Staff Training
Internal and External Auditing
Product Release and Batch Record reviews
Quality record reviews, inspections and maintenance
Data Trending and Analytics
QUALIFICATIONS
Bachelor’s degree in Science, Engineering or related discipline with 8+ years of experience leading a team
Master’s degree in Science, Engineering or related discipline with 5+ years of experience leading a team
Doctoral degree in Science, Engineering or related discipline with 3+ years of experience leading a team
Experience with External Regulatory Agency audits (i.e., Notified Bodies and FDA)
Experience as front room lead during external audits
Experience with Training program development / implementation
Six Sigma, CQA, and/or CQE preferred
Knowledge of Oracle ERP is preferred
Knowledge of Trackwise is preferred
Knowledge of Agile Product lifecycle management system preferred
Demonstrated organizational and analytical skills
Strong communication skills, both written and verbal
Expert knowledge in quality system and regulatory documentation writing and editing skills (i.e., CAPA, NC)
Excellent leadership skills with a team-focused attitude
Demonstrated knowledge and understanding of applicable national and international regulations and standards
Computer literacy—experience with Microsoft Outlook, Word, Excel, and Access database
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 | EOE including Disability/Protected Veterans
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 . If you have difficulty using our online system due to a disability and need an accommodation, please email us at [email protected] or call us at 855-936-2666.
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