QA Senior Specialist

Posted 7 Days Ago
Be an Early Applicant
Tokyo, JPN
In-Office
Senior level
Healthtech • Manufacturing
The Role
Leads local labeling, product release, incoming inspection, and quality activities. Coordinates manufacturing, distribution, and 3PL partners; evaluates nonconforming products; investigates quality issues; performs root cause analysis; supports CAPA, complaint investigations, audits, regulatory inspections, and quality system compliance. Develops procedures and work instructions, trains personnel, and drives quality improvement initiatives.
Summary Generated by Built In

Changing lives. Building Careers.
Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

Key Duties and Responsibilities

  • Lead and manage local labeling operations and product release activities in compliance with applicable regulatory and quality requirements.
  • Plan and oversee local incoming inspection activities and ensure appropriate release decisions are made based on established quality standards.
  • Coordinate local manufacturing, labeling, and distribution activities with 3PL partners and internal stakeholders.
  • Provide training, guidance, and oversight to 3PL personnel to ensure adherence to approved procedures and quality requirements.
  • Evaluate nonconforming products and determine appropriate disposition.
  • Identify, investigate, and report product quality issues and nonconformities.
  • Perform root cause analysis and support CAPA implementation.
  • Drive quality improvement initiatives to enhance product quality, compliance, and operational effectiveness.
  • Develop and maintain quality procedures, local manufacturing work instructions, and related quality documentation.
  • Support complaint investigations and product evaluations, including visual inspection and functional testing, as required.
  • Support internal and external audits, regulatory inspections, and quality system compliance activities.
  • undefined

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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The Company
HQ: Princeton, New Jersey
3,489 Employees

What We Do

Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative technology product portfolio to include surgical instruments, neurosurgical products and advanced wound care products, through global acquisitions and development of new and innovative products and technologies to address unmet patient needs and improve outcomes. Integra is a global leader in neurosurgery and offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Our regenerative tissue technologies include products that address soft tissue, nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. The company has offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas. Integra products are ubiquitous in many hospital intensive care units and operating rooms around the world. Some of our high quality leading brands include AmnioExcel®, Bactiseal®, CerebroFlo®, CereLink® Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, Gentrix®, ICP Express®, Integra®, MatriStem® UBM, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, NeuraGen® 3D, PriMatrix®, SurgiMend®, TCC-EZ® and VersaTru® and are available through a combination of directly employed sales representatives, distributors and wholesalers

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