Redbock - an NES Fircroft company
1 day ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Base pay range This range is provided by Redbock - an NES Fircroft company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
$35.00/hr - $45.00/hr
CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY
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:
Requires a Bachelor’s Degree and 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:
Partner 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.
Must Have:
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.
Nice To Have:
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)
Seniority level
Not Applicable
Employment type
Contract
Job function
Industries
Biotechnology Research and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Redbock - an NES Fircroft company by 2x
Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Disability insurance
Get notified about new Quality Engineer jobs in
Greater Boston .
Boston, MA $70,000.00-$90,000.00 1 day ago
Fitchburg, MA $70,000.00-$90,000.00 2 weeks ago
Marlborough, MA $78,000.00-$122,100.00 5 days ago
Marlborough, MA $86,600.00-$164,500.00 1 week ago
Woburn, MA $80,000.00-$120,000.00 6 days ago
Manchester, NH $65,000.00-$110,000.00 1 week ago
Quincy, MA $72,800.00-$138,300.00 1 week ago
Billerica, MA $77,821.00-$91,555.00 5 days ago
Woburn, MA $80,000.00-$120,000.00 1 day ago
West Brookfield, MA $75,000.00-$115,000.00 1 week ago
Mansfield, MA $100,000.00-$130,000.00 6 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Get AI-powered advice on this job and more exclusive features.
Base pay range This range is provided by Redbock - an NES Fircroft company. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
$35.00/hr - $45.00/hr
CANDIDATES CURRNETLY WORKING UNDER F1 OPT/F1 OPT STEM/H1-B WILL NOT BE CONSIDERED. W2 CANDIDATES ONLY
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:
Requires a Bachelor’s Degree and 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:
Partner 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.
Must Have:
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.
Nice To Have:
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)
Seniority level
Not Applicable
Employment type
Contract
Job function
Industries
Biotechnology Research and Medical Equipment Manufacturing
Referrals increase your chances of interviewing at Redbock - an NES Fircroft company by 2x
Inferred from the description for this job
Medical insurance
Vision insurance
401(k)
Disability insurance
Get notified about new Quality Engineer jobs in
Greater Boston .
Boston, MA $70,000.00-$90,000.00 1 day ago
Fitchburg, MA $70,000.00-$90,000.00 2 weeks ago
Marlborough, MA $78,000.00-$122,100.00 5 days ago
Marlborough, MA $86,600.00-$164,500.00 1 week ago
Woburn, MA $80,000.00-$120,000.00 6 days ago
Manchester, NH $65,000.00-$110,000.00 1 week ago
Quincy, MA $72,800.00-$138,300.00 1 week ago
Billerica, MA $77,821.00-$91,555.00 5 days ago
Woburn, MA $80,000.00-$120,000.00 1 day ago
West Brookfield, MA $75,000.00-$115,000.00 1 week ago
Mansfield, MA $100,000.00-$130,000.00 6 days ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr