Katalyst CRO · 11 hours ago
Sr Quality Engineer
Danvers, MA
Contract
Onsite
Senior Level
5+ years expKatalyst CRO is seeking a Senior Quality Engineer to provide comprehensive manufacturing quality support for commercial medical devices. The role involves developing and maintaining quality standards, collaborating with engineering and manufacturing functions, and ensuring compliance with industry standards and regulatory requirements.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
Responsibilities
Provide Quality Engineering support for commercial medical device products
Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product
Collaborate with engineering and manufacturing functions to ensure quality standards are in place
Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Design or specify 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
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
Apply knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing
Ensure changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements
Able to present quality during new product introduction projects and provide quality support for documentation changes, change control, process transfer and equipment installation Present technical data to groups within and outside the organization
Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings
Qualification
Required
Medical Device Design & Development
Risk Management: dFMEA, pFMEA, Statistical analysis
Technical Writing: IQs, PQs, TMVs
Hands on experience on upstream new product development vs downstream manufacturing transfer and operations quality
Working knowledge of Quality System Regulation (QSR 21 CFR 820), Canadian Medical Device Regulation (CMDR), EU Medical Device Directive (EU MDD 93/42 EEC), JPAL, and ISO 13485:2016
Demonstrated working knowledge of process validation, statistical methods, risk management
Bachelor's Degree in Engineering, Science or technical field AND 5-7 years of work experience in Engineering and/or Quality OR Advanced Degree in Engineering, Science or technical field AND 2 years of work experience in Engineering and/or Quality
Preferred
Green Belt Six Sigma/DRM Training/Certification is preferred, but not required
ASQ-CQE, CQA, CBA or equivalent certifications preferred, but not required
SAP QM or SPC Software experience preferred, but not required
Company
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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