Senior Quality Assurance Engineer

2 weeks ago


Frederick, Maryland, United States Theradaptive Full time
Job Title: Senior Quality Engineer

Theradaptive is a pioneering company in the field of therapeutic delivery, revolutionizing the industry with a pipeline of innovative products addressing multiple global markets. Our cutting-edge science combines biology and orthopedic tissue repair, pushing the boundaries of regenerative medicine.

We are seeking a highly skilled Senior Quality Engineer to join our innovative team. This individual will play a pivotal role in establishing and maintaining robust quality systems and processes to support our clinical trials and manufacturing processes.

Key Responsibilities:
  • Establish and maintain quality systems, policies, and procedures related to OOS, Deviations, CAPAs, NCMRs, and Complaints.
  • Support analytical test method qualification plans, protocols, and reports from a quality perspective.
  • Assist with risk analysis activities and maintain up-to-date risk management documents.
  • Develop and implement quality inspection plans for the release of components, assemblies, and finished devices.
  • Support Manufacturing, R&D/Product Development, Analytical Development, and Quality Control with statistical techniques, including design of experiments (DOE) and sampling plans.
Requirements:
  • Minimum of a BS in Biomedical Engineering, Chemical Engineering, Biochemistry, Chemistry, or equivalent degree.
  • 5+ years of relevant experience in Biologics, pharmaceuticals, and/or medical devices and combination products.
  • Fluency in reading, writing, and speaking Japanese.
  • Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971.
  • Highly motivated and self-directed with a strong sense of urgency.
  • Excellent communication skills at different organizational levels.
What We Offer:

Theradaptive is an equal opportunity employer. We offer a dynamic work environment, competitive compensation, and opportunities for professional growth and development.



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