Senior Quality Assurance Manager

1 week 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.

Our Lead Therapeutics:

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

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

Job Summary:

We are seeking a highly skilled Senior Quality Engineer with medical device experience to ensure the implementation of robust quality systems and processes. This role will play a pivotal part in establishing and maintaining quality standards, conducting risk assessments, and driving continuous improvement initiatives to meet regulatory requirements and industry best practices.

Responsibilities:
  • Establish quality systems/policies related to OOS, Deviations, CAPAs, NCMRs, and Complaints, and work with various departments to ensure timely closure of related investigations.
  • Support from a quality perspective, analytical test method qualification plans/protocols and reports.
  • Assist with risk analysis activities and maintaining up to date risk management documents.
  • Establish Quality Inspection Plans for the release of components, assemblies, and finished devices. Conduct quality inspections as needed.
  • Support Manufacturing and R&D/Product Development, Analytical Development and Quality Control with statistical techniques, including design of experiments (DOE); sampling plans and data/results analysis.
  • Utilize statistical techniques, including design of experiments (DOE) and sampling plans to analyze results effectively.
  • Support quality management programs such as supplier selection and certification. Perform supplier evaluations as needed to assure supplier capabilities including the assessment of the adequacy of inspection methods, manufacturing practices, and control and quality procedures to deliver conforming products in a timely manner.
  • Lead supplier audits and works 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 and provide guidance and feedback.
  • Quality oversight on all product development procedures to identify deviations from quality standards.
  • Quality oversight on all product manufacturing processes and systems.
  • Quality oversight on all manufacturing output and ability to compare properties to requirements.
  • Quality oversight on the sterilization and product release processes.
Qualifications:
  • Minimum of a BS in Biomedical Engineering, Chemical Engineering, Biochemistry, Chemistry or equivalent degree.
  • 5+ years relevant experience in medical devices. Experience in Biologics/Pharmaceutics or combination products is a plus.
  • Must have a 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 is a plus.
  • Highly motivated and self-directed with a strong sense of urgency, with an ability to pull in resources from other departments as required.
  • Must be able 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, observant.
  • Excellent Communications Skills (oral, written, presentation) at different organizational levels.
  • Experience with statistical techniques and tools.
  • Experience with root cause analysis tools and methods.
  • Certification(s) in quality engineering (e.g., 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. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, ethnic or national origin, ancestry, pregnancy (including childbirth or related condition), citizenship, familial status, mental or physical disability, veteran status, genetic information, other non-disqualifying disability, or any other characteristic protected by law.

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