Integra LifeSciences QA Specialist in United States
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."
Quality System Management
Prepare/revise/control SOPs and forms to ensure compliance with Japan QMS requirements.
Act as document controller to manage QMS documents
Educate and train QMS for Integra Japan staff
Gain and maintain ISO13485 certificate.
QMS audit for both internal and external
Product Release and Distribution
Perform in-coming QC and release Integra products in compliance with PMD Act
Manage labeling for products in compliance with PMD Act
Manage foreign manufacturers (FMR, Quality agreement, Periodic confirmation)
Resolution of quality issue and CAPA
Manage product recall
Support QMS Application for Japanese distributor
POLO Supplier approvals and management
Local supplier audits as required by division/corporate
Education and Experience
Degree in pharmacy or scientific field
Minimum 5-8 year QA experience in Pharmaceutical / Medical Device (Class IV) Industries
Essential Skills and Abilities
Excellent verbal and written communication skills
Ability to multiple tasks, prioritize and work under pressure
Strong negotiation skills with Japan authorities (MHLW, PMDA, TMG, Notified body)
Good organization skills and ability
Business level English
Computer skills – MS-Word, Excel, PowerPoint
Vacancy ID 2018-26387
Position Type Regular Full-Time
Category Quality Assurance