Senior Quality Assurance Specialist

4 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.


  • Frederick, Maryland, United States Unicon Pharma Inc Full time

    Job SummaryUnicon Pharma Inc is seeking a highly skilled Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in quality control and assurance, with excellent analytical and problem-solving skills.Key Responsibilities:Conduct quality control testing and analysis to ensure compliance with cGMP guidelines and...


  • Frederick, Maryland, United States LeadStack Inc. Full time

    Job Title: Quality Assurance SpecialistLeadStack Inc. is a leading provider of contingent workforce solutions, partnering with top Fortune 500 brands. We're seeking a highly motivated Quality Assurance Specialist to join our team.Job Summary:We're looking for a detail-oriented Quality Assurance Specialist to support our manufacturing site. The ideal...


  • Frederick, Maryland, United States Pave Talent Full time

    Job Title: Quality Assurance SpecialistJob Summary:We are seeking a detail-oriented Quality Assurance Specialist to join our team on third shift. As a Quality Assurance Specialist, you will play a crucial role in maintaining product quality and ensuring compliance with food safety standards.Key Responsibilities:Conduct verifications of manufacturing...


  • Frederick, Maryland, United States Crescent City Recruitment Group Full time

    Quality Assurance SpecialistAt Crescent City Recruitment Group, we are seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products and processes, working closely with cross-functional teams to identify and implement improvements.Key Responsibilities:Develop and implement...


  • Frederick, Maryland, United States RICEFW Technologies Full time

    Job Title: Quality Assurance SpecialistJob Summary:RICEFW Technologies is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing testing and analysis of raw materials, intermediates, and final products. You will also be...


  • Frederick, Maryland, United States Theradaptive Full time

    Job DescriptionTheradaptive is a pioneering company in the field of therapeutic delivery, with a pipeline of innovative products addressing multiple global markets. Our team is dedicated to advancing regenerative medicine, working at the intersection of biology and orthopedic tissue repair.We are seeking a highly skilled Senior Quality Engineer to ensure the...


  • Frederick, Maryland, United States Collabera Full time

    Job Summary:Collabera is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products by performing testing and analysis of raw materials, intermediates, and final products. You will work closely with internal and external resources to maintain a...


  • Frederick, Maryland, United States ATR International Full time

    Job SummaryWe are seeking a highly motivated Quality Assurance Specialist to join our team at ATR International. The successful candidate will be responsible for ensuring compliance with quality systems and identifying and assessing regulatory and quality risks in activities and processes.Key Responsibilities:Provide QA support on the production floorEnsure...


  • Frederick, Maryland, United States Varite Full time

    Job Summary:As a Quality Assurance Specialist at Varite, you will provide critical support to our documentation processes and systems. Your responsibilities will include creating logbooks and control-issued documents, maintaining the document archival room, and ensuring the accuracy and retrievability of files. You will also scan, verify, and archive...


  • Frederick, Maryland, United States Collabera Full time

    Job Summary: We are seeking a highly skilled Quality Assurance Specialist to join our team at Collabera. The successful candidate will be responsible for performing testing of raw materials, intermediates, and final products by following analytical methods such as cell-based bioassays, Flow Cytometry, ELISA, and qPCR assays. The ideal candidate will have a...


  • Frederick, Maryland, United States Mindlance Full time

    Job Title: QA AssociateAt Mindlance, we are seeking a highly organized and detail-oriented Quality Assurance Specialist to join our team. The successful candidate will provide clerical and administrative support related to documentation processes and systems. Key responsibilities include creating logbooks and other control issued documents, maintaining the...


  • Frederick, Maryland, United States Theradaptive Full time

    Job Summary:We are seeking a highly motivated Senior Quality Engineer to join our team at Theradaptive. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality and compliance are met for our organization.This role will play a pivotal part in establishing and maintaining robust quality systems and processes...


  • Frederick, Maryland, United States BioSpace, Inc. Full time

    Job Title: Lead GCLP Quality Assurance SpecialistJob Summary:The Frederick National Laboratory is seeking a highly skilled Lead GCLP Quality Assurance Specialist to join our team. As a key member of our laboratory, you will be responsible for leading continuous performance evaluation of internal controls, communications, risk assessments, and maintenance of...


  • Frederick, Maryland, United States eTeam Full time

    Job Summary:As a Quality Assurance Specialist at eTeam, you will be responsible for providing clerical and administrative support related to documentation processes and systems. This includes creating logbooks and other control issued documents, assisting in maintaining the document archival room, and ensuring files are accurate and easily retrievable. You...


  • Frederick, Maryland, United States Srisai Biopharmaceutical Solutions Full time

    At Srisai Biopharmaceutical Solutions, we are seeking a talented Quality Assurance Compliance Specialist to join our dynamic and collaborative team. As a key member of our QA team, you will play a critical role in ensuring company compliance with approved procedures and applicable regulatory standards.The Compliance Specialist will work closely with the QA...


  • Frederick, Maryland, United States Cornerstone Recruiting Full time

    Job Summary:The Quality Assurance Technician is responsible for ensuring quality products are produced in the plant according to specifications. This includes ensuring food safety procedures are followed, customer expectations and specifications are met, and product quality and safety information is analyzed to identify trends.Key Responsibilities:Assure...


  • Frederick, Maryland, United States Chili's Grill & Bar Full time

    As a Quality Assurance Specialist at Chili's Grill & Bar, you will play a vital role in ensuring that every Guest receives perfectly prepared, high-quality food. Your dependable nature and ability to work in a fast-paced environment will make you a valuable asset to our team. You will be responsible for ensuring food is prepared to company standards and...


  • Frederick, Maryland, United States Walmart Full time

    About the Role:This position is responsible for overseeing patient safety and quality for pharmacy non-store operations at Central Fill facilities. The primary responsibility is to collaborate with various stakeholders within health and wellness to enhance patient safety and quality of care.Key Responsibilities:Investigate patient safety events, identify...


  • Frederick, Maryland, United States Walmart Full time

    About the RoleThis position will oversee patient safety and quality for pharmacy non-store operations at Central Fill facilities in Frederick, MD and Rogers, AR.Key ResponsibilitiesCollaborate with various stakeholders within health and wellness, including Compliance, Operations, and Legal, to enhance patient safety and quality of care within the...


  • Frederick, Maryland, United States Walmart Full time

    About the RoleThis position is responsible for overseeing patient safety and quality for pharmacy non-store operations at Central Fill facilities in Frederick, MD and Rogers, AR.Key ResponsibilitiesCollaborate with various stakeholders within health and wellness, including Compliance, Operations, and Legal, to enhance patient safety and quality of care...