Integra LifeSciences

Changing lives. Building Careers.

Joining us is a chance 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, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

The Product Release Supervisor provides technical and supervisory leadership and mentoring to Product Release group members and provides support to management. Directs, coordinates, and evaluates the activities of associates in the Product Release group ,including, Device History Record (DHR) review, final review and release of finished product, issuance of Certificate of Compliance, and adherence to all applicable regulations, policies, and procedures. Must have working knowledge of U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, the European Medical Device Directive, Canadian Medical Device Regulations, and other applicable regulatory agencies/ requirements.

SUPERVISION EXERCISED

Directly supervises all Product Release specialists

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Responsible for supervising all Product Release personnel and operations, including Device History Record (DHR) review, final review and release of finished product, issuance of Certificate of Compliance for Integra LifeSciences OEM partners and customers as requested and in accordance with previously agreed upon regulatory requirements.
• Provides staff with leadership, support, and mentoring. Conducts performance reviews for Product Release personnel, holds regular team meetings, and provides training to junior staff as needed.
• Works with all facets of the company including technical representatives from manufacturing, validation and the laboratories to assure that all issues are resolved in a timely fashion and that any special studies performed in manufacturing are accurately documented and reported in the batch record.
• Participate in internal audit program of departments and processes at the site.
• Participate in and support external audits where needed.
• Support company goals and objectives, policies, and procedures, and Quality System Regulations (QSR).
• Perform other related duties as required

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• Bachelor’s degree or higher in scientific or regulatory discipline, or related field.
• 5-7 years of relevant Quality Assurance experience in regulated industry, with supervisory and project leadership experience.
• Must have strong written and verbal communication skills. Must be able to effectively present at staff and department meetings.
• Knowledge of MS Office Suite

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 careers@integralife.com.

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