Quality Systems Manager

Vital Bio; Oakville; Hybrid; CAD 110,000 - 145,000; Full time

Job summary

Vital Bio seeks a detail-oriented quality professional with deep medical device experience to own end-to-end QMS and act as the eQMS subject matter expert. You will lead audits, CAPA, and design control activities while partnering with R&D, Manufacturing, and Supply Chain to embed quality and compliance.

The role demands 7+ years in regulated QA, strong governance of ISO 13485, and experience with eQMS platforms. This is a full-time, hybrid position in Ontario, Canada.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Quality, or related technical field.
• Minimum 7 years in QA or Quality Systems within regulated medical devices.
• Minimum 3 years leading Quality Systems.
• Experience maintaining ISO 13485 QMS and eQMS systems.
• Experience administering and optimizing eQMS platforms.
• Experience leading eQMS implementations, upgrades, migrations, validations, or harmonization.
• Experience supporting FDA inspections, MDSAP audits, ISO 13485 cert audits, and customer audits.
• Strong knowledge of ISO 13485, FDA QMSR, MDSAP, Health Canada Medical Device Regulations, ISO 14971, CAPA, supplier quality, audits, and data integrity (ALCOA+).

Responsibilities

• Own, maintain, and improve the QMS, ensuring compliance with ISO 13485, FDA QMSR, MDSAP, and Health Canada regulations.
• Serve as eQMS business owner, configuring workflows, forms, permissions, training curricula, and dashboards.
• Lead eQMS implementations, upgrades, and validations with IT and vendors.
• Plan and manage internal, external, certification, customer audits, and regulatory inspections.
• Oversee CAPA, deviation, nonconformance, and change control with root cause investigations.
• Lead Management Review and develop quality dashboards for executives.
• Ensure document control: creation, approval, revision, archiving of QMS documents and training records.
• Support product development with design control, verification, validation, and transfer.
• Ensure ISO 14971 risk management and review changes for regulatory impact.
• Support supplier qualification, audits, and corrective actions.
• Lead complaint handling, investigations, and post-market surveillance activities.
• Identify and drive quality improvement initiatives using risk-based decisions.

Skills

QMS ownership

eQMS administration

ISO 13485

FDA QMSR

MDSAP

Audit management

CAPA/root cause

Document control

Design control

Risk management

Regulatory compliance

Stakeholder management

Education

Bachelor's degree

Tools

MasterControl

Greenlight Guru

Veeva

ETQ Reliance

TrackWise

Arena QMS

Job description

About you:
You are a detail-oriented quality professional with strong medical device experience and a track record of owning Quality Management Systems end to end. You're comfortable serving as the eQMS subject matter expert and business process owner, balancing compliance requirements with business objectives in a fast-paced product development and manufacturing environment. You bring strong leadership, stakeholder management, and analytical skills, and you're motivated to embed quality and compliance across R&D, Manufacturing, Operations, and Supply Chain.

About you:
You are a detail-oriented quality professional with strong medical device experience and a track record of owning Quality Management Systems end to end. You're comfortable serving as the eQMS subject matter expert and business process owner, balancing compliance requirements with business objectives in a fast-paced product development and manufacturing environment. You bring strong leadership, stakeholder management, and analytical skills, and you're motivated to embed quality and compliance across R&D, Manufacturing, Operations, and Supply Chain.
What you'll do:

• Own, maintain, and continuously improve the Quality Management System (QMS), ensuring compliance with ISO 13485, FDA QMSR, MDSAP, Health Canada Medical Device Regulations, and other applicable global requirements.
• Serve as business owner and administrator of the eQMS, configuring and optimizing workflows, forms, permissions, training curricula, and dashboards.
• Lead eQMS implementations, upgrades, enhancements, and validation activities, partnering with IT and external vendors on system performance and compliance.
• Plan and manage internal quality audits, and coordinate external audits, certification audits, customer audits, and regulatory inspections.
• Oversee CAPA, deviation, nonconformance, and change control processes, ensuring effective root cause investigations and monitoring quality trends.
• Lead Management Review activities, developing and maintaining quality dashboards and performance metrics for senior leadership.
• Ensure effective document control processes, including creation, approval, revision, and archival of quality system documents and training records.
• Support product development activities in accordance with design control requirements, including design reviews, verification, validation, and design transfer.
• Ensure risk management activities are conducted in accordance with ISO 14971 and review product/process changes for quality and regulatory impact.
• Support supplier qualification, monitoring, audits, and corrective action programs.
• Support complaint handling, investigations, and post-market surveillance activities, including trending and regulatory reporting as required.
• Identify and lead quality improvement initiatives across the organization, applying risk-based decision making.

What you’ll need:

• Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Quality, or a related technical discipline.
• Minimum 7 years of experience in Quality Assurance or Quality Systems within a regulated medical device environment.
• Minimum 3 years of experience managing or leading Quality Systems.
• Demonstrated experience maintaining and improving ISO 13485-certified Quality Management Systems.
• Demonstrated experience administering, maintaining, and optimizing electronic Quality Management Systems (eQMS).
• Experience leading eQMS implementations, upgrades, migrations, validations, or process harmonization projects.
• Experience supporting FDA inspections, MDSAP audits, ISO 13485 certification audits, and customer audits.
• Experience supporting product development, design controls, verification, validation, and commercialization activities.
• Strong knowledge of ISO 13485, FDA QMSR, MDSAP, Health Canada Medical Device Regulations, ISO 14971, CAPA/root cause methodologies, supplier quality management, internal/external auditing, document control, CSV, and data integrity principles (ALCOA+).

Bonus points for:

• Diagnostics, IVD, point-of-care diagnostics, molecular diagnostics, or laboratory instrumentation experience.
• Master's degree.
• Experience with MasterControl, Greenlight Guru, Veeva, ETQ Reliance, TrackWise, Arena QMS, or equivalent regulated eQMS platforms.
• ASQ Certified Quality Auditor (CQA), ASQ CMQ/OE, ISO 13485 Lead Auditor, Lean Six Sigma, or Regulatory Affairs Certification (RAC).

Why join us:
At Vital Bio, you will:

• Help bring innovative medical technology to life and make a real impact on how healthcare is delivered.
• You will work across disciplines to turn ambitious ideas into manufacturable products, with the opportunity to shape how we launch, scale, and improve them.
• If you want to build something meaningful with a team that values trust, agility, and ownership, this is the place for you.

The compensation range for this role is $110,000 - $145,000.
Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.
This role is a full-time, hybrid vacancy.
About Vital Bio
Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.
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.