Integra LifeSciences QA Manager in Tokyo, Japan

Overview

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."

Responsibilities

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.

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 product recall

Others

  • Support QMS Application for Japanese distributor

  • Manage FMR

Qualifications

Qualifications

  • QA Manager regulated in PMD Act

Education and Experience

  • Bachelor's degree

  • 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

Competencies

  • Business level English

  • Native level Japanese

  • Computer skills – MS-Word, Excel, PowerPoint

Vacancy ID 2018-26295

Location JP-Tokyo

Position Type Regular Full-Time

Category Quality Assurance

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 stat