Quality Product Release Specialist

7 days ago


Lakewood, United States Terumo BCT Full time

Job Summary:

As a Quality Product Release Specialist at Terumo Blood and Cell Technologies, you will play a critical role in ensuring the quality and regulatory compliance of our medical devices. This position requires a high level of attention to detail, strong analytical skills, and the ability to work independently with minimal supervision.

Key Responsibilities:

  • Review and approve Device History Records (DHRs) and other records to ensure compliance with regulatory and quality guidelines.
  • Coordinate and obtain all required documentation for a complete DHR.
  • Provide accurate and timely turnaround time for approval on product release documentation and SAP release transactions.
  • Support internal efforts to improve timeliness and ensure product quality to external customers.
  • Interpret, execute, and recommend modifications to operating policies, SOPs, and WINs, where appropriate.
  • Support customer requests for established product certificates (Certificates of Compliance).
  • Update and maintain all product release indices, where appropriate.
  • Support non-US based facilities in meeting Quality System and regulatory requirements.
  • Maintain regulatory required records per record retention requirements.
  • Participate in internal and external quality audits regarding Release paperwork, SAP transactions, and Policies/SOPs/WINS.

Requirements:

  • Bachelor's degree or equivalent education and experience.
  • Minimum 2 years experience in a manufacturing environment.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
  • Develops or participates in the development of solutions to problems of moderate to intermediate complexity.
  • Demonstrated knowledge of manufacturing protocols, statistical tools and methodology, continuous improvement techniques, and basic project management skills.

Physical Requirements:

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range: $34.00 to $ Hourly pay rate to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Target Bonus on Base: 7.0%



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