Integra LifeSciences Sr Quality Assurance Engineer in Cincinnati, Ohio
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."
Escalate and/or present CAPA program to Site or Corporate Management.
Become the Subject Matter Expert for the CAPA program during Notified body audits or FDA Inspections.
Support Manufacturing and Project Teams by developing DOEs, FMEAs, statistically sound tests, and process controls for appropriate support of results. Develop statistically valid sampling plans for QC and validation activities.
Lead or Co-lead improvement/investigation efforts at the base business level, working hand to hand with Manufacturing Engineers and Machinists.
Leads or participates in activities related to non-conformances (MRB), Corrective & Preventative Actions (CAPA support), and complaints.
Document Change Order support. Initiate or approve change packages, ensuring process is implemented properly and QA issues have been addressed.
Work with Product Development team in order to ensure all aspects of Design Transfer activities are being met. Formulate product quality plans based on results of risk analysis.
Internal Audit Program participation. Work with the established audit plan to complete audits and prepare audit reports.
Actively participate in the Supplier Management program. Audit the quality system of new and existing suppliers and prepare audit reports including recommendations. Act as the Technical Specialist in supplier-related quality issues. Oversee supplier corrective actions when appropriate.
Ensure that all projects are in compliance with GMP, QSR (including Design Controls), ISO or other applicable requirements.
Write and coordinate efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR compliance
Identify and implement opportunities for continuous improvement.
Strong knowledge on Risk Management tools as per ISO14971: 2012.
Experience in High Precision machining process is highly desired.
- Bachelors Degree in a scientific or technical discipline, Master’s degree preferred.
Minimum of 5-7 years experience in a Quality Assurance role for manufacturing (or 3 years with Masters Degree).
Medical device or pharmaceutical industry experience is required.
Experience on High Precision machining process is highly desired.
ASQ Certification as a CQE or CQA desired.
Auditing experience highly preferred
Six Sigma (Green Belt or Black Belt) preferred
Skills & Abilities:
Strong skills in technical writing.
Strong Statistical and Risk Management applicability skills
Strong interpersonal, organizational, and communication skills and respect for confidentiality.
Demonstrates knowledge of statistical sampling and analysis, including DOE design.
Must be able to work independently with minimal supervision.
Vacancy ID 2018-25970
Position Type Regular Full-Time
Category Quality Assurance