Senior Quality Assurance Specialist
4 weeks ago
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.
- 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.
- On-site at Theradaptive corporate headquarters and laboratory in Frederick, MD.
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