Quality Engineer - Medical Device - Westerly, RI

Michael Page International

Westerly, RI

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JOB DETAILS

SALARY

$90,000–$110,000 Per Year

JOB TYPE

Full-time

SKILLS

Bill of Materials (BOM), Change Control, Channel Support, Cleanroom, Code of Federal Regulations, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Data Processing, ERP (Enterprise Resource Planning), FDA (Food and Drug Administration), Healthcare Software, ISO (International Organization for Standardization), Industry Standards, Leading Edge Technology, MPI, Manufacturing, Manufacturing Operations, Medical Equipment, Medical Products, Minitab, Patient Care, Presentation/Verbal Skills, Problem Solving Skills, Process Failure Mode and Effects Analysis (PFMEA), Process Improvement, Process Quality, Process Validation, Production Part Approval Process (PPAP), Quality Engineering, Quality Metrics, Regulations, Safety/Work Safety, Software Validation, State Laws and Regulations, Statistics, Writing Skills

LOCATION

Westerly, RI

POSTED

12 days ago

As a Quality Engineer, you'll partner cross‑functionally with engineering, manufacturing, and operations to ensure product and process excellence in a regulated environment. You'll drive continuous improvement, lead validation and CAPA activities, and play a hands‑on role in maintaining world‑class quality standards. Client Details Our client is a global manufacturing partner supporting cutting‑edge medical technology used in critical healthcare applications. They combine advanced cleanroom facilities with a strong quality culture and a commitment to innovation, safety, and continuous improvement. Description Drive product and process quality using data‑driven, industry‑standard problem‑solving toolsLead MRB activities, manage NCRs, and oversee corrective and preventive actions to completionOwn process and software validation activities, including PFMEA, IQ/OQ/PQ, PPAP, and FAIRAnalyze manufacturing and validation data to reduce variation, defects, and wasteManage internal and customer change controls, ensuring alignment to specificationsPartner with operations and ERP teams on routing and BOM approvalsSupport customer complaints through structured root‑cause analysisParticipate in internal, customer, and regulatory auditsMaintain a strong presence on the manufacturing floor to support quality excellence Profile 1-3 years of experience in a medical device manufacturing environmentStrong knowledge of ISO 13485 and FDA CFR Part 820 requirementsHands‑on experience with CAPA, validations, and statistical analysis (Minitab preferred)Excellent written, verbal, and cross‑functional communication skillsExperience working in fast‑paced, regulated manufacturing settings Job Offer Work on mission‑critical medical products that improve patient outcomesGain exposure to full lifecycle quality engineering and validation workCollaborate with experienced engineering and operations teamsAccess advanced cleanroom manufacturing environmentsJoin a company that values quality, safety, and continuous improvement MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

About the Company

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/