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 combines biology and orthopedic tissue repair, pushing the boundaries of regenerative medicine.

  • Spinal Fusion
  • Long Bone Repair
  • Osteochondral Repair
  • Dental and Facial Bone Repair
  • Immuno-Oncology

We are a fast-paced, innovative team advancing diverse translational research projects. Our mission is to ensure the highest standards of quality and compliance for our organization.

Job Summary:

We are seeking a seasoned Senior Quality Engineer with medical device experience to lead our quality assurance efforts. This role will play a pivotal part in establishing and maintaining robust quality systems and processes, ensuring compliance with regulatory requirements and industry best practices.

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 and R&D/Product Development, Analytical Development, and Quality Control with statistical techniques, including design of experiments (DOE) and sampling plans.
  • Lead supplier audits and work with suppliers to resolve audit findings and/or nonconformances.
  • Perform internal audits as needed.
  • Review specifications for products or processes and set requirements for raw material or intermediate products for suppliers.
  • 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 medical devices, with experience in Biologics/Pharmaceutics or combination products a plus.
  • Complete understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971.
  • Experience in Biologics/Pharmaceutics or combination regulatory requirements, 21 CFR 211, and ICH Quality Guidelines a plus.
  • Highly motivated and self-directed, with a strong sense of urgency and ability to pull in resources from other departments as required.
  • Excellent communication skills, with the ability to interface well with Management, Manufacturing, and R&D/Product Development, Analytical Development, and Quality Control.
  • Ability to deliver, meet deadlines, and be results-oriented.
  • Detail-oriented, thorough, and observant.
  • 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, a plus.
Position Location:
  • On-site at Theradaptive corporate headquarters and laboratory in Frederick, MD.

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