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.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Lead in the identification and completion of CAPA activities, including CAPA investigations.

• Coach NC owners and Review NC phases

• Work with functional management to ensure NC are completed with quality an integrity in a timely manner

• Support MRB meetings and CAPA management

• Assist or lead Nonconforming product activities, including investigations and coordination/management of MRB review and approval.

• Supports design changes, process changes and new product development through team involvement and review and approval of documentation.

• Establishes and maintains Quality Management System procedures related to areas of responsibilities.

• Collects and reports quality metrics as required.

DESIRED MINIMUM QUALIFICATIONS:

• Bachelor’s degree or equivalent with 8+ years of experience, master’s degree with 5+ years of experience, Doctoral degree with 3+ years of experience.

• Must have bachelor’s degree or higher in Engineering, or Biological Sciences discipline.

• Experience with CAPA and nonconforming product processes.

• Experience with process/test method/equipment validations.

• Strong technical aptitude (i.e. able to read and comprehend technical documentation, ability to comprehend and execute procedures, demonstrated understanding of system documentation).

• Knowledge of statistical sampling and analysis.

• Working knowledge of medical device regulations (including FDA QSRs, ISO13485).

• Ability to communicate effectively (both written and oral).

• Must be able to observe company policies and safety procedures at all times.

• Demonstrated ability to work cross-functionally in a team environment.

• Quality Engineering/ Quality Compliance/ Quality Assurance experience in the Medical Device or similar FDA regulated industry.

• Certified Quality Engineer preferred, but not required.

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.

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