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Quality Engineer II

US–MA–Boston, Vacancy ID2023-44539

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Changing lives. Building careers.

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.”

RESPONSIBILITIES

Responsibilities

The Quality Engineering team focuses 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, Manufacturing Engineering, Design Engineering and Post-Market Surveillance groups to ensure a high level of product quality and effective and efficient investigations when needed.

Primary responsibilities for this role:

• Assist or lead customer complaint investigations and post-market surveillance activities.

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

• 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.

• 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.

• Collects and reports quality metrics as required.

• Participates in internal and external audits.

Position is site based (on-site).

QUALIFICATIONS

What are we looking for?

Qualifications

• Minimum required education and experience: Bachelor degree or equivalent with 5+ years of experience, Master degree with 3+ years of experience, Doctoral degree with 0-2 years of experience

• Bachelor’s degree required in Quality Assurance, Biological Sciences or discipline.

• Quality Engineering in the Medical Device or similar FDA regulated industry.

• 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.

• Certified Quaity Engineer preferred, but not required.

The employee must repeatedly sit, listen, speak, stand and move throughout the facility. The employee is required to be boots on the ground and spend time in all manufacturing areas. The employee must be able to lift items of up to 25-30 lbs.

In an effort to minimize the spread of the coronavirus and to protect our employees, all new hires in the US and Puerto Rico will need to be fully vaccinated for COVID-19 in order to be considered for employment with Integra LifeSciences, unless eligible for an accommodation as provided by law.

OUR PRODUCTS

We are proud of our 25 year heritage as a leader in regenerative medicine. Today, our scientific innovation and diverse product portfolio continue to help patients and surgeons around the world.

OUR CULTURE

We have an entrepreneurial, small company feel, yet deliver big company results. Your ideas – big and small – are welcome here. We embrace change and reward our people who are committed to making Integra a stronger company.

OUR VALUES

We believe how we do things is as important as what we do. Our Values guide how we work and how we act towards our customers, patients and each other every day. We value Our People, Integrity, Excellence, Embracing Change, Decisiveness and Teamwork.

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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