Quality Engineer II
Redbock - an NES Fircroft companyBillerica, MA, US2 days ago
Job type
- Full-time
Job descriptionPartner with Manufacturing Engineering and Supervisors to assess and determine routes for non-conformances (NCs) and potential NCs Conduct quality line walks to ensure compliance and audit readiness Own and collaborate on Quality Management System (QMS) and Process change orders Represent Quality in process improvement projects Collaborate with cross-functional teams to resolve quality issues Ensure corrective actions and documentation meet regulatory and internal standards Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and / or research and development as they apply to product or process quality. 3+ years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management. Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations. Proven experience leading NCMR and CAPA processes, ideally within a medical device or regulated industry. Strong project management / coordination skills, with the ability to manage multiple priorities and deadlines. Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions. Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders. Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability. Experience in Process Validation. Experience working in a clean room or regulated manufacturing environment. DMAIC, process mapping, 5 Whys, Is / Is Not analysis - scientific problem-solving methodologies Experience with Map change control systems Familiarity with SAP ERP manufacturing systems and electronic manufacturing execution systems (MES)
Quality Engineer II (Through end of May 2026 / / Billerica, MA) :
Alternate Title : Quality Specialist
Top 3 Required Skills :
- Experience working in a clean room or regulated manufacturing environment.
- 3+ years of experience in the medical device industry, with a strong background in Non-Conforming Materials Reports (NCMR), CAPA, or product quality management.
- Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions
Education Required & Years' Experience Required : Bachelor's Degree and a minimum of 2 years of relevant experience
Description :
Seeking a professional with 3+ years' experience in medical device quality management, including NCMR, CAPA, and process validation. Requires strong knowledge of FDA (21 CFR Part 820), ISO 13485, EU MDR, and related regulations. Proven ability to lead NCMR and CAPA processes.
Duties :
Must Have :
Nice To Have :
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Quality Engineer Ii • Billerica, MA, US
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