Senior Quality Assurance Engineer
2 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.
We are seeking a highly skilled Senior Quality Engineer to join our innovative team. This individual 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 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, R&D/Product Development, Analytical Development, and Quality Control with statistical techniques, including design of experiments (DOE) and sampling plans.
- 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.
- Fluency in reading, writing, and speaking Japanese.
- Understanding of regulatory requirements for the medical device industry, specifically 21 CFR 820, ISO 13485, and ISO 14971.
- Highly motivated and self-directed with a strong sense of urgency.
- Excellent communication skills at different organizational levels.
Theradaptive is an equal opportunity employer. We offer a dynamic work environment, competitive compensation, and opportunities for professional growth and development.
-
Senior Software Quality Assurance Engineer
2 weeks ago
Frederick, Maryland, United States ManTech Full timeSecure Our Nation, Ignite Your FutureAt ManTech International, we're seeking a skilled Senior Software Quality Assurance Engineer to join our team in Frederick, Maryland. As a key member of our Agile team, you'll play a critical role in ensuring the quality of our software solutions.Responsibilities:Develop and execute comprehensive software test plans to...
-
Senior Software Quality Assurance Engineer
4 weeks ago
Frederick, Maryland, United States ManTech Full timeSecure Our Nation, Ignite Your FutureAt ManTech International, we're committed to protecting our nation's security while fostering a culture of innovation and growth. As a Senior Software Test Engineer, you'll play a critical role in ensuring the quality of our software solutions.Key Responsibilities:Develop and execute comprehensive software test plans to...
-
Senior Software Quality Assurance Engineer
2 weeks ago
Frederick, Maryland, United States ManTech Full timeSecure Our Nation, Ignite Your FutureAt ManTech International, we're seeking a skilled Senior Software Quality Assurance Engineer to join our team in Frederick, Maryland. As a key member of our Agile team, you'll play a critical role in ensuring the quality of our software solutions.Responsibilities:Develop and execute comprehensive software test plans to...
-
Senior Quality Assurance Manager
1 week ago
Frederick, Maryland, United States Theradaptive Full timeJob Title: Senior Quality EngineerTheradaptive 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...
-
Software Quality Assurance Engineer and Tester
3 weeks ago
Frederick, Maryland, United States ManTech Full timeSecure Our Nation, Ignite Your FutureAt ManTech International, we're seeking a motivated and customer-oriented Software Quality Assurance Engineer and Tester to join our team in Frederick, Maryland.Responsibilities:Develop and execute software test plans to ensure quality software is provided for release to production.Create test plans with test cases based...
-
Quality Assurance Specialist
2 weeks ago
Frederick, Maryland, United States R&D Partners Full time{"h3": "Job Description"} Your Key Responsibilities: • Provide quality assurance support on the production floor. • Ensure process control measures are in place and followed in product manufacturing. • Receive and manage incoming apheresis material. • Oversee and authorize shipment of final products. • Verify and ensure timely issuance of...
-
Quality Assurance Specialist
3 weeks ago
Frederick, Maryland, United States Chimera Enterprises International Full timeJob Title: Quality Assurance SpecialistChimera Enterprises International is seeking a highly skilled Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) JPEO-CBRND Medical Office. The JPEO-CBRND manages our nation's investments in chemical, biological,...
-
Software Quality Assurance Engineer and Tester
4 weeks ago
Frederick, Maryland, United States ManTech Full timeSecure Our Nation, Ignite Your FutureAt ManTech International, we're seeking a motivated and customer-oriented Software Quality Assurance Engineer and Tester to join our team in Frederick, Maryland. As a key member of our team, you'll play a critical role in ensuring the quality of our software solutions.Responsibilities:Develop and execute comprehensive...
-
Quality Assurance Specialist
7 days ago
Frederick, Maryland, United States Leonardo DRS Full timeJob Title: Quality Assurance SpecialistLeonardo DRS is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for assisting with quality system development and supporting product quality improvements.Key Responsibilities:Develop, maintain and deploy quality plans and activities that translate...
-
Quality Assurance Specialist
5 days ago
Frederick, Maryland, United States GForce Life Sciences Full timeQuality Assurance EngineerWe are seeking a highly skilled Quality Assurance Engineer to join our team at GForce Life Sciences. As a key member of our analytical wet-chemistry lab, you will be responsible for ensuring the quality and integrity of our products.Key Responsibilities:Raw Materials & Product Testing: Conduct raw materials, in-process, finished...
-
Quality Assurance Specialist
3 weeks ago
Frederick, Maryland, United States Net2Source Inc. Full timeJob Title - Quality Assurance Specialist I -Grade 25Location - OnsiteDuration: 06 month contractShift - Sunday – Wednesday 7am- 5:30 pmPay Rate: $36.71/hr. on W2About the Role:We are seeking a highly motivated individual to join our team as a Quality Assurance Specialist. In this role, you will support the activities of the Quality Assurance department at...
-
Quality Assurance Specialist
2 weeks ago
Frederick, Maryland, United States ATR International Full timeJob Title: Quality Assurance SpecialistWe are seeking a highly motivated individual to join our team as a Quality Assurance Specialist. In this role, you will support the activities of the Quality Assurance department at our manufacturing site in Frederick, MD.Key Responsibilities:Provide QA support on the production floorEnsure process control measures are...
-
Quality Assurance Specialist
3 weeks ago
Frederick, Maryland, United States Intelliswift Software Full timeJob Title: QA Manufacturing Lot DispositionsLocation: Frederick, MDDuration: 6+ MonthsResponsibilities:Provide quality assurance support on the production floor.Ensure process control measures are in place and followed in product manufacturing.Manage the receipt and disposition of incoming apheresis material.Oversee and authorize the shipment of final...
-
Quality Assurance Specialist
2 weeks ago
Frederick, Maryland, United States Net2Source Inc. Full timeJob Title - Quality Assurance Specialist I -Grade 25Location - Frederick, MD OnsiteDuration: 06 month contractShift - Shift is Sunday – Wednesday 7am- 5:30 pmPay Rate: $36.71/hr. on W2Job Summary:We are seeking a highly motivated Quality Assurance Specialist to join our team at Net2Source Inc. in Frederick, MD. As a Quality Assurance Specialist, you will...
-
Quality Assurance Specialist
2 weeks ago
Frederick, Maryland, United States Collabera Full timeJob Title: QA Specialist ICollabera is seeking a highly skilled QA Specialist I to join our team. As a QA Specialist I, you will be responsible for ensuring the quality of our products and processes.Responsibilities:Provide QA support on the production floorEnsure process control measures are in place and followed in product manufacturingReceipt and...
-
Quality Assurance Supervisor
1 week ago
Frederick, Maryland, United States SriSai Biopharma Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Supervisor to join our team at SriSai Biopharmaceutical Solutions. The successful candidate will be responsible for ensuring the quality of our products and services, and will play a key role in maintaining our company's reputation for excellence.Key ResponsibilitiesDevelop and implement quality...
-
Quality Assurance Lead
3 weeks ago
Frederick, Maryland, United States NVR Full timeJob Title: Quality Assurance LeadNVR is seeking a highly skilled Quality Assurance Lead to join our team in Frederick, MD. As a Quality Assurance Lead, you will be responsible for leading a team of QA analysts to ensure the quality and reliability of systems for our manufacturing business.Key Responsibilities:Lead the QA team in designing, implementing, and...
-
Quality Assurance Manager
3 weeks ago
Frederick, Maryland, United States Treasure Health Full timeJob Title: Quality Enhancement and Compliance ManagerWe are seeking a highly skilled Quality Enhancement and Compliance Manager to lead our efforts in ensuring the highest quality and compliance standards in our services and supports for individuals with developmental disabilities.Key Responsibilities:Develop and implement quality assurance protocols to...
-
Quality Assurance Supervisor
7 days ago
Frederick, Maryland, United States SriSai Biopharma Full timeJob SummaryWe are seeking a highly skilled Quality Assurance Supervisor to join our team at SriSai Biopharmaceutical Solutions. The successful candidate will be responsible for ensuring the quality of our products and services, and will play a key role in maintaining our company's reputation for excellence.Key ResponsibilitiesLead and manage a team of...
-
Quality Assurance Manager
6 days ago
Frederick, Maryland, United States Saputo Full timeJob Summary:The Quality Assurance Manager is responsible for ensuring the production and distribution of products meet or exceed all quality standards. This includes safeguarding product safety and quality while meeting Company and regulatory standards, as well as overseeing a continuous quality improvement program that includes quality control and quality...