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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.

The Quality CAPA Engineer works closely with the Engineering/Maintenance teams with a focus on product compliance in support of Product Design and Manufacturing, including the critical quality system elements of CAPA, Complaint Investigations, Risk Management, Process/Test Method/Equipment Validations, Deviations, Control of Nonconforming Product, Product Holds, Microbiology and Equipment management.  Works closely with Operations, Project and Manufacturing Engineering, Maintenance, and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient investigations when needed.

ESSENTIAL DUTIES AND RESPONSIBILITIES

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

Primary responsibilities are to:

Assist or lead in the identification and completion of CAPA activities, including CAPA investigations.

Write and Review CAPAs

Work with functional management to ensure CAPAs are completed with quality and integrity

Support CAPA and CRB meetings and in the NC and CAPA management

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

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

Develops and implements test method validations as assigned.

Reviews and approves validation protocols and reports for new and existing processes and equipment.

pFMEA development and updates.

Supports risk management file updates.

Establishes statistically based sampling plans for inspections, verifications, validations, etc.

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

Ensures compliance with cGMP, QSR, ISO 13485, MDD/EU MDR, and other applicable regulations and standards.

Utilizes the Computerized Maintenance Management System and manual file systems for investigations.

Collects and reports quality metrics as required.

Participates in internal and external audits.

Position is site based (on-site).

DESIRED MINIMUM QUALIFICATIONS

Bachelor degree or equivalent with 3+ years of experience, Master degree with 2-5 years of experience.

Must have Bachelor 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.

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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 or call us at 855-936-2666.

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