Senior Quality Engineer Consultant (3-6 Month Contract)
Top Benefits
About the role
About you: You are a passionate, hands-on Senior Quality Engineer who thrives in fast-paced, high-growth startup environments. You have a strong command of quality systems, regulatory standards, and risk management for medical devices or diagnostics, and you excel at turning strategy into action—no task too small or too complex. You take pride in balancing big-picture thinking with tactical execution, and you’re energized by the possibility of building exceptional, scalable processes from the ground up. Collaboration, agility, and resourcefulness are your trademarks, and you’re ready to roll up your sleeves to help shape the future of innovative diagnostics at Vital Bio.
What you’ll do:
- Act as a key quality advisor and hands-on contributor, collaborating across R&D, engineering, manufacturing, and operations to build and maintain a best-in-class quality culture.
- Develop, implement, and continually improve quality processes, SOPs, and documentation aligned with ISO 13485, FDA QSR, and other relevant standards for medical devices/IVDs.
- Lead or support risk management activities (e.g., FMEAs, risk files), verification & validation (V&V) planning and execution, and complaint/CAPA investigations.
- Partner closely with cross-functional teams to ensure quality is embedded throughout the product development lifecycle—including design controls, DHF, DMR, and change management.
- Support supplier quality activities: qualifying new vendors, supporting audits, reviewing quality agreements, and addressing non-conformities and corrective actions.
- Execute hands-on quality activities and testing, perform root cause analysis, and drive practical, efficient resolutions to quality issues.
- Prepare for and facilitate internal and external audits, helping the company maintain inspection readiness and compliance as it scales.
- Review and approve documentation, design history files, and manufacturing records to ensure accuracy, completeness, and regulatory conformity.
- Mentor and coach team members on quality principles, fostering ownership and a proactive approach to risk and compliance.
- Dive into tactical projects—whether it’s validating test methods, streamlining document control, or implementing change control—ensuring efficient, timely execution.
- Champion a culture of continuous improvement, providing feedback and actionable insights to strengthen quality at every stage.
What you’ll need:
- Bachelor’s degree in engineering, life sciences, or a related technical field.
- 7+ years of direct quality engineering experience in medical device, diagnostics, or IVD sector (startup and scale-up experience strongly preferred).
- In-depth knowledge of ISO 13485, FDA QSR, and GxP requirements relevant to emerging diagnostics or medical device startups.
- Demonstrated ability to efficiently execute hands-on quality tasks, from document review to test method validation and issue resolution.
- Experience with design controls, risk management (FMEA), CAPA, and supplier quality in a dynamic environment.
- Excellent problem-solving, organizational, and communication skills with a collaborative, can-do attitude.
- Proven track record of balancing strategic initiatives with day-to-day quality operations in a rapid-growth, resourceful setting.
Bonus points for:
- Experience in pre-commercial or newly commercializing medical device/IVD companies.
- ASQ Certified Quality Engineer (CQE), auditor certification, or Lean/Six Sigma credentials.
- Familiarity with electronic QMS platforms and digital quality tools.
- A genuine enthusiasm for startups, creative problem-solving, and the occasional pun!
Why join us: At Vital Bio, you will:
- Play a hands-on, foundational role in building and evolving quality processes that will define our next-generation diagnostics platform.
- Collaborate daily with passionate experts across disciplines in a purpose-driven, transparent, and agile culture.
- Take ownership of your work, see your impact at every stage, and help lay the groundwork for scalable, sustainable growth.
- Grow alongside a team that values trust, learning, and bold thinking—as we democratize healthcare access for patients everywhere.
About Vital 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.
About Vital Bio
Vital was created to enable proactive, preventative, and accessible healthcare. We're starting with a radically disruptive approach to lab testing. Backed by many years of R&D by world-class scientists and engineers, we are a team of collaborators, re-engineering the nature of care delivery.
Senior Quality Engineer Consultant (3-6 Month Contract)
Top Benefits
About the role
About you: You are a passionate, hands-on Senior Quality Engineer who thrives in fast-paced, high-growth startup environments. You have a strong command of quality systems, regulatory standards, and risk management for medical devices or diagnostics, and you excel at turning strategy into action—no task too small or too complex. You take pride in balancing big-picture thinking with tactical execution, and you’re energized by the possibility of building exceptional, scalable processes from the ground up. Collaboration, agility, and resourcefulness are your trademarks, and you’re ready to roll up your sleeves to help shape the future of innovative diagnostics at Vital Bio.
What you’ll do:
- Act as a key quality advisor and hands-on contributor, collaborating across R&D, engineering, manufacturing, and operations to build and maintain a best-in-class quality culture.
- Develop, implement, and continually improve quality processes, SOPs, and documentation aligned with ISO 13485, FDA QSR, and other relevant standards for medical devices/IVDs.
- Lead or support risk management activities (e.g., FMEAs, risk files), verification & validation (V&V) planning and execution, and complaint/CAPA investigations.
- Partner closely with cross-functional teams to ensure quality is embedded throughout the product development lifecycle—including design controls, DHF, DMR, and change management.
- Support supplier quality activities: qualifying new vendors, supporting audits, reviewing quality agreements, and addressing non-conformities and corrective actions.
- Execute hands-on quality activities and testing, perform root cause analysis, and drive practical, efficient resolutions to quality issues.
- Prepare for and facilitate internal and external audits, helping the company maintain inspection readiness and compliance as it scales.
- Review and approve documentation, design history files, and manufacturing records to ensure accuracy, completeness, and regulatory conformity.
- Mentor and coach team members on quality principles, fostering ownership and a proactive approach to risk and compliance.
- Dive into tactical projects—whether it’s validating test methods, streamlining document control, or implementing change control—ensuring efficient, timely execution.
- Champion a culture of continuous improvement, providing feedback and actionable insights to strengthen quality at every stage.
What you’ll need:
- Bachelor’s degree in engineering, life sciences, or a related technical field.
- 7+ years of direct quality engineering experience in medical device, diagnostics, or IVD sector (startup and scale-up experience strongly preferred).
- In-depth knowledge of ISO 13485, FDA QSR, and GxP requirements relevant to emerging diagnostics or medical device startups.
- Demonstrated ability to efficiently execute hands-on quality tasks, from document review to test method validation and issue resolution.
- Experience with design controls, risk management (FMEA), CAPA, and supplier quality in a dynamic environment.
- Excellent problem-solving, organizational, and communication skills with a collaborative, can-do attitude.
- Proven track record of balancing strategic initiatives with day-to-day quality operations in a rapid-growth, resourceful setting.
Bonus points for:
- Experience in pre-commercial or newly commercializing medical device/IVD companies.
- ASQ Certified Quality Engineer (CQE), auditor certification, or Lean/Six Sigma credentials.
- Familiarity with electronic QMS platforms and digital quality tools.
- A genuine enthusiasm for startups, creative problem-solving, and the occasional pun!
Why join us: At Vital Bio, you will:
- Play a hands-on, foundational role in building and evolving quality processes that will define our next-generation diagnostics platform.
- Collaborate daily with passionate experts across disciplines in a purpose-driven, transparent, and agile culture.
- Take ownership of your work, see your impact at every stage, and help lay the groundwork for scalable, sustainable growth.
- Grow alongside a team that values trust, learning, and bold thinking—as we democratize healthcare access for patients everywhere.
About Vital 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.
About Vital Bio
Vital was created to enable proactive, preventative, and accessible healthcare. We're starting with a radically disruptive approach to lab testing. Backed by many years of R&D by world-class scientists and engineers, we are a team of collaborators, re-engineering the nature of care delivery.