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Integra LifeSciences

QA Senior Specialist

Integra LifeSciences Tokyo, Japan

Medical Equipment Manufacturing · 1,001-5,000 employees

2 d ago
qa Senior (5-10 yrs) Full-time Japan
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About the role

Lead and manage local labeling operations, product release activities, and incoming inspections to ensure compliance with quality standards. Coordinate with 3PL partners and internal stakeholders while driving quality improvement initiatives and managing nonconformities.

What they look for

Quality Assurance Regulatory Compliance Labeling Operations Product Release Incoming Inspection 3PL Management Root Cause Analysis CAPA Quality Improvement Complaint Investigation Visual Inspection Functional Testing Internal Audits Regulatory Inspections Quality Documentation

Requirements

The role requires experience in quality assurance, regulatory compliance, and managing manufacturing or distribution operations. Candidates must be capable of performing root cause analysis, supporting audits, and overseeing quality documentation.

Full description

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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