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- Plainsboro Center, NJ 08536
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Quality Engineer II
Integra Life Sciences • Plainsboro Center, NJ
Posted 26 days ago
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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 3,300 employees worldwide. Integra's common stock is listed on The NASDAQ Stock Market under the symbol 'IART.'
Provide Quality Assurance Engineer support production activities (post market, product and process) to ensure processes and products developed and implemented meet specified standards and specifications and comply with the quality system and applicable regulatory requirements and recognized standards. The Quality Assurance Engineer plays a critical role in the Company’s Quality System Requirements.
- Provide quality leadership to one of the SSS product franchises.
- Perform trend & reliability analysis on the business franchise signals (e.g. complaints, events, service & repair, etc.)
- Assist in verification and validation activities to support the Design and Development team or manufacturing improvements.
- Works with engineering and manufacturing during to ensure quality deliverables (FMEA, Control Plans, Inspection Plans, Inspection Equipment and Tooling) are in place prior to Design Transfer.
- Use CAPA methodology to analyze and evaluate product defects and perform failure investigations to determine root cause, failure modes, and implement corrective and preventive actions and/or recommend modifications that lead to product enhancements.
- Investigates, dispositions, and resolves nonconforming material events during product development, preproduction and production phases.
- Apply statistical techniques and process improvement techniques to operational challenges.
- Work with Engineering and purchasing on vendor selection, qualifications and control. May include audit of existing or perspective vendors.
- Assist in ensuring overall regulatory compliance including but not limited to; FDA, ISO 13485 certification and the company’s Quality Management System.
- Interpret company policies/procedures and QSR/GMP requirements applicable to work area. Implement new and revised quality procedures and train new employees and existing staff on quality procedures for areas of responsibility update.
- Assist in the planning, conducting and documenting internal quality management system audits.
- Participate in regulatory inspections, including ISO and FDA surveillance audits.
- Perform quality monitoring associated with manufacturing and post market outcomes.
- Bachelor of Science Degree in Mechanical, Electronic, Biomedical or Industrial Engineering or equivalent.
- Two years or more in a related field (Medical Devices)
- Good working knowledge of Quality System Regulation (QSR), with particular emphasis on Design Controls, ISO 13485:2003 regulations and statistical techniques.
- CQE Certified Quality Engineer preferred
- Must be self-motivated, detail oriented and have strong analytical and problem solving skills.
- PC literacy a must proficient in Word, Excel and Access.