First Officer

Transat; Mississauga; On-site; CAD 130,000 - 150,000; Full time

Job summary

Vital Biosciences Inc. in Ontario seeks a Senior Manufacturing Quality Engineer to lead quality activities for new product introduction and sustained production of medical devices.

You will collaborate across Manufacturing Engineering, Process Engineering, R&D, Operations, Supply Chain, and Regulatory Affairs to build robust, compliant processes. The role requires deep expertise in process characterization, validation, DOE/ SPC, and continuous improvement within a regulated environment, with

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Manufacturing, Chemical, Industrial Engineering.
• 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.

Responsibilities

• Lead manufacturing quality activities supporting 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.
• Lead process characterization studies to establish critical process parameters and operating windows.
• Drive yield improvement, scrap reduction, defect reduction, and process optimization initiatives.
• Work closely with cross-functional teams to enable efficient product launches and sustained manufacturing.

Skills

Quality engineering

Statistical analysis

Process validation

Lean Six Sigma

Cross-functional leadership

Education

Bachelor's degree in Mechanical, Biomedical, Manufacturing, Chemical, Industrial Engineering

Tools

Minitab

JMP

Job description

Full-time +1

The Senior Manufacturing Quality Engineer is a 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.

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.

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.

Compensation: $130,000 – $150,000 CAD annually, commensurate with experience.

Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.

We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.

Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance.

As part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision-making. Final hiring decisions are always made by our hiring team.