Our direct client is looking for a Senior Quality Engineer with strong background in Medical Devices, working onsite in Oakville / Mississauga, ON, Canada.
Senior Quality Engineer - (Medical Device)
Location: Oakville / Mississauga, ON (Onsite 5 Days/Week)
Onsite role, Monday – Friday
Employment Type: Full-Time
Technical leader responsible for ensuring manufacturing processes consistently produce safe, effective, and high-quality medical devices. This individual partners closely with Manufacturing Engineering, Process Engineering, R&D, Operations, Supply Chain, and Regulatory Affairs to develop, validate, monitor, and continuously improve manufacturing processes from development through commercialization and sustained production. This role requires deep expertise in process characterization, statistical engineering, validation, and continuous improvement within a regulated medical device environment.
Senior Quality Engineer - Key Responsibilities
- Focus on Quality Management System (QMS) processes, compliance, and continuous improvement.
- Support compliance with FDA regulations, 21 CFR Part 820, and ISO 13485 requirements.
- Lead and manage CAPA activities, including root cause analysis, corrective actions, preventive actions, and effectiveness checks.
- Conduct and support internal quality audits and supplier quality audits.
- Interface with regulatory bodies and support regulatory inspections/audits as needed.
- Maintain and improve quality documentation, procedures, records, and controlled documents.
- Develop and maintain quality training programs and ensure employee training compliance.
- Manage and investigate non-conformances, including root cause analysis, corrective actions, and documentation.
- Partner cross-functionally to ensure ongoing QMS compliance and quality system effectiveness.
Qualifications
- Bachelor's degree in Mechanical, Biomedical, Manufacturing, Chemical, Industrial Engineering, or related engineering discipline.
- Minimum 10 years of Quality Engineering experience in the medical device industry.
- Minimum 7 years supporting manufacturing operations and process validation.
- Demonstrated expertise in automated manufacturing, process characterization, statistical analysis, and commercialization.
- ASQ Certified Quality Engineer (CQE) preferred.
- Lean Six Sigma Green Belt or Black Belt preferred.
Required Technical Expertise
- Process Characterization, IQ/OQ/PQ, PPQ, Equipment Qualification, Process Validation, Revalidation.
- DOE, SPC, Cp/Cpk/Ppk, ANOVA, Regression Analysis, Statistical Sampling, Minitab, JMP.
- Test Method Development & Validation, Gage R&R, MSA, Attribute Agreement Analysis.
- PFMEA, Control Plans, Sampling Plans, Risk Analysis, Process Capability, Root Cause Analysis, CAPA.
- Lean Manufacturing, Six Sigma, Yield Improvement, Cost Reduction, Continuous Improvement.
Success Measures
- Commercially ready manufacturing processes with demonstrated capability.
- Improved yield, reduced defects, and statistically capable manufacturing processes.
- Successful execution of validation activities supporting commercialization.
- Robust process controls and monitoring strategies using SPC.
- Effective cross-functional partnership enabling efficient product launch and sustained manufacturing.
- Consistent compliance with regulatory and Quality Management System requirements.
Key Responsibilities
- Lead manufacturing quality activities supporting new product introduction (NPI), commercialization, and sustaining manufacturing.
- Partner with Manufacturing Engineering during equipment design, process development, automation, and design transfer.
- Develop and execute manufacturing quality strategies that ensure robust, scalable, and compliant manufacturing processes.
- Ensure compliance with FDA QMSR, ISO 13485, ISO 14971, and internal Quality Management System requirements.
Process Characterization & Validation
- Lead process characterization studies to establish critical process parameters and operating windows.
- Author, execute, and approve IQ, OQ, PQ, PPQ, equipment qualification, process validation, and revalidation protocols.
- Perform process capability studies and statistical analysis to support validation conclusions.
- Prepare comprehensive validation reports and technical documentation.
Statistical Engineering
- Serve as the manufacturing statistical expert applying DOE, SPC, Cp/Cpk/Ppk, ANOVA, regression analysis, confidence intervals, and statistical sampling.
- Analyze manufacturing data using Minitab (required) and JMP (preferred).
- Develop control charts, capability analyses, and data-driven recommendations to improve process performance.
Test Method Development & Validation
- Develop, optimize, and validate inspection and test methods.
- Lead Test Method Validation activities.
- Perform Gage R&R, Measurement System Analysis (MSA), and Attribute Agreement Analysis.
Manufacturing Process Improvement
- Drive yield improvement, scrap reduction, defect reduction, and process optimization initiatives.
- Develop and maintain PFMEAs, Control Plans, Inspection Plans, Sampling Plans, and Process Monitoring Plans.
- Lead manufacturing investigations, root cause analysis, CAPAs, and corrective actions using structured problem-solving methodologies.
Cross-Functional Leadership
- Work closely with Manufacturing Engineering, Process Engineering, Operations, R&D, Supply Chain, Regulatory Affairs, Quality Systems, and suppliers.
- Provide technical leadership during pilot builds, engineering builds, process transfers, and commercial scale-up.
Location: Oakville / Mississauga, Ontario (Onsite 5 Days per Week)
If you are interested, please send me your updated Word Resume, along with your direct phone number and email.
