Senior Quality Engineer - Medical Device - Hopkinton, RI

Michael Page International

Hopkinton, Rhode Island

JOB DETAILS
SALARY
$100,000–$115,000 Per Year
JOB TYPE
Full-time
SKILLS
Analysis Skills, Bill of Materials (BOM), Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), Healthcare, ISO (International Organization for Standardization), Manufacturing, Medical Equipment, Minitab, Presentation/Verbal Skills, Problem Solving Skills, Process Quality, Process Validation, Quality Engineering, Registrar, Root Cause Analysis, Software Administration, Software Validation, Structured Analysis, Test Case, Validation Testing
LOCATION
Hopkinton, Rhode Island
POSTED
1 day ago
Job TitleDrive product and process quality using statistical tools, audits, and structured problem-solving methodologiesLead and maintain process validations, including PFMEAs, OQ/PQ, PPAPs, FAIRs, and validation reportsManage MRB activities, NCRs, and CAPA, ensuring effective corrective actions and follow-upAnalyse manufacturing and validation data to reduce variation, waste, and defectsReview and control internal and external changes, including customer specificationsSupport ERP-related activities including route and BOM approvalsLead and support software validation activities, including test cases and validation documentationInvestigate customer complaints using structured root cause analysis techniquesSupport internal, customer, and registrar audits as requiredAbout Our ClientThis organisation is a well-established manufacturer operating in a highly regulated industry, known for its technical complexity and commitment to quality. The culture values collaboration, accountability, and people who enjoy making tangible improvements in how products are built and validated.The Successful ApplicantBachelor's degree in Engineering or a related technical/scientific discipline1-3 years' experience in a medical device manufacturing environmentStrong working knowledge of ISO 13485:2016 and familiarity with FDA CFR Part 820Hands-on experience with process, product, and software validationStrong analytical skills; experience with statistical tools (Minitab preferred)Experience with ERP systems and a fast-paced manufacturing environmentExcellent written and verbal communication skillsWhat's on OfferHigh-impact role with real ownership of quality and validation activitiesExposure across engineering, manufacturing, and operationsOpportunity to strengthen regulated industry expertiseStrong emphasis on continuous improvement and best practicesStable environment with long-term growth potentialJob SummarySector: Engineering & ManufacturingSub Sector: Quality, TechnicalIndustry: Healthcare / PharmaceuticalWhere: InternationalContract Type: PermanentConsultant name: Taylor RankinJob Reference: JN-052026-7028979

About the Company

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Michael Page International

Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world. Our business was established in Canada in 2005 when we opened our Toronto office. Our role is to work with employers and job seekers to facilitate a successful match. This can range from advising a global company on a candidate sourcing strategy to helping a job seeker find their dream job. In Canada, we focus on recruiting for the following areas: Banking and financial services Digital and e-commerce Engineering and manufacturing Finance and accounting Human resources Information technology Marketing Oil and gas Procurement and supply chain Property and construction Sales An Established Brand The Group has established a leading presence in many of the key markets for professional recruitment around the world and has positioned itself in certain other markets, which offer the opportunity for future growth. Within its current largest markets, Michael Page has also built a regional presence, including in the UK, France and Australia. Consequently, the Michael Page brand is among the most widely recognized brands in the professional recruitment industry. A Market Leader The role of a recruitment consultancy is to act as an intermediary, identifying and sourcing suitably qualified candidates on behalf of its clients. Candidates are recruited either for permanent or contract positions (typically for a fixed term) or on a temporary basis. Within the overall recruitment industry, the market for professional recruitment services is a specialist sector which has developed more recently. Michael Page is widely recognized as leading the development of this market around the world. Learn the benefits of working with Michael Page yourself. Submit your resume or contact a Michael Page recruitment consultant today.
COMPANY SIZE
10,000 employees or more
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.michaelpage.ca/