Senior Quality Assurance Specialist

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 in regenerative medicine combines biology and orthopedic tissue repair, pushing the boundaries of what is possible.

We are seeking a highly skilled Senior Quality Engineer to join our team, fluent in Japanese and English, to ensure the highest standards of quality and compliance are met. This role 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 quality systems and policies related to OOS, Deviations, CAPAs, NCMRs, and Complaints, working closely with various departments to ensure timely closure of related investigations.
  • Support quality aspects, including analytical test method qualification plans/protocols and reports.
  • Assist with risk analysis activities and maintain up-to-date risk management documents.
  • Establish Quality Inspection Plans for the release of components, assemblies, and finished devices, conducting quality inspections as needed.
  • Support Manufacturing and R&D/Product Development, Analytical Development and Quality Control with statistical techniques, including design of experiments (DOE) and sampling plans.
  • Utilize statistical techniques to analyze results effectively.
  • Support quality management programs, including supplier selection and certification, performing supplier evaluations as needed.
  • Lead supplier audits and work with suppliers to resolve audit findings and/or nonconformances.
  • Perform internal audits as needed.
  • Responsible for quality engineering review of Document Change Orders.
  • Review specifications for products or processes.
  • Set requirements for raw material or intermediate products for suppliers and monitor their compliance.
  • Ensure adherence to regulatory requirements and health and safety guidelines.
  • Supervise inspectors, technicians, and other staff, providing guidance and feedback.

Qualifications:

  • 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.
  • Must be fluent in reading, writing, and speaking Japanese.
  • Must have a strong understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971, or the Biologics/Pharmaceutics industry, specifically 21 CFR 211 and ICH Quality Guidelines.
  • Highly motivated and self-directed with a strong sense of urgency, able to pull in resources from other departments as required.
  • Excellent communication skills, including oral, written, and presentation skills at different organizational levels.
  • Experience with statistical techniques and tools, as well as root cause analysis tools and methods.
  • Certification(s) in quality engineering, such as ASQ Certified Quality Engineer, is a plus.

Position Location:

On-site at Theradaptive corporate headquarters and laboratory in Frederick, MD.

Theradaptive is an equal opportunity employer, committed to diversity and inclusion. We welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy, citizenship, familial status, mental or physical disability, veteran status, genetic information, or any other characteristic protected by law.

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