The Quality Systems Manager will manage the Product Quality Systems, Document Control and Complaint Investigations teams ensuring overall site QMS compliance, including the critical quality system elements of Document Control, Training, Corrective and Preventive Action, Quality Plans, Audit Management (internal and external), Management Review, Quality Metrics, and Product Complaint Investigations. Will serve as alternate Quality Management Representative for site with responsibilities including Quality Management Review preparation, and Audit/Inspection Backroom leadership. Works closely with all functional leaders to ensure on-going compliance and improvement.
Bachelor’s degree in Quality Assurance or related discipline or 7-10 years’ experience in QA/Compliance within the Medical Device industry.
Minimum 7 years’ experience in the Medical Device industry, minimum 1-3 years in a supervisory role.
Extensive experience with development and implementation of quality management systems.
Expert knowledge of medical device regulations (including FDA QSRs, ISO 13485, EU MDR, ANVISA, Japan Ordinance 169, ATG).
Experience with developing and improving Document Control and Records Control processes.
Experience with CAPA processes including investigational techniques.
Experience with Training program development/implementation.
Experience conducting QMS/Quality training.
Experience leading/hosting external audits, and conducting internal audits. Certified Quality Auditor is a plus.
Experience implementing QMS process improvements.
Experience in personnel management and mentoring. Demonstrated ability in successfully leading a team.
Ability to work independently with minimal supervision. Comfortable making level appropriate decisions.
Ability to communicate effectively at all levels of the organization.
Ability to influence, lead and drive positive change across an organization.
Certified Quality Manager, Certified Quality Auditor desired but not required.
About Integra LifeSciences
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.”