Integra LifeSciences Corporation
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QA Engineer II
at Integra LifeSciences Corporation
- Vacancy ID
- Position Type
- Regular Full-Time
- Quality Assurance
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.
Integra's orthopedic products include devices and implants for foot and ankle, hand and wrist, shoulder and elbow, tendon and peripheral nerve protection and repair. Integra is a leader in neurosurgery, offering a broad portfolio of implants, devices, instruments and systems used in neurosurgery, neuromonitoring, neurotrauma, and related critical care. Integra’s Tissue Technologies is an in-patient and outpatient Regenerative product portfolio, which includes products for wound care, burns, abdominal reconstruction, and plastic & reconstructive surgery. In the United States, Integra is a leading provider of surgical instruments to hospitals, surgery centers and alternate care sites, including physician and dental offices.
Founded in 1989 Integra is headquartered in Plainsboro, New Jersey and has over 4,500 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol "IART."
- Support the launch of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective. Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met.
- Facilitate the development of product risk documentation, including Design FMEAs, Hazard Analysis and other documentation as deemed appropriate.
- Develop statistically based sampling plans for validation/verification testing.
- Work with Product Development to develop DOEs and statistically sound tests for appropriate support of results.
- Utilize quality system data sources to understand and characterize product and process performance
- Collect and appropriately analyze different types of data to support appropriate decision making.
- Independently summarize and adequately present data in a manner that clearly and concisely supports quality decisions.
- Independently conduct investigations and adequately summarize results and conclusions as deemed appropriate.
- Uses various brainstorming/investigation tools such as fishbone diagrams, 5-why, and FMEA, to support thorough investigation strategies and approaches to root cause analysis.
- As required, lead the prompt execution of root cause analysis of Nonconformance and various failure investigations. Additionally, lead Corrective & Preventative Action(s) implementation and/or review.
- Lead the implementation of process improvements through the utilization continuous improvement methodologies and techniques from the point of new product transfer support through process validation and production realization.
- Lead implementation and maintain SPC programs with Manufacturing and Quality Control through the use of Process Control Planning.
- Participate in FDA inspections, ISO Certification and surveillance audits and customer audits.
- Interact and coordinate activities with other departments, external vendors and customers.
- Bachelor’s Degree in Engineering (Biomedical, mechanical, chemical, or electrical) or Science (Biology).
- 2 to 4 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
- Demonstrates excellent knowledge of statistical sampling and analysis tools/methods to support data-driven decision making
- Demonstrates excellent organizational, verbal and written communication skills
- Proficient with the MS Office Suite, and statistical software.
- Must be able to work independently with minimal supervision.
- Able to prioritize projects and manage assigned Quality resources to meet organizational goals and objectives