Senior Quality Assurance Specialist

Siemens Healthineers AG; Ottawa; On-site; CAD 73,000 - 105,000; Full time

Job summary

Siemens Healthineers Canada is seeking a Senior Quality Assurance Specialist to lead CAPA activities, support the QMS and site Quality Operations, and ensure regulatory and procedural compliance across functions. The role involves investigations, escalation, and driving improvements for product quality and patient safety.

Reporting to QA Operations, this role provides technical leadership on site Quality Systems and works with manufacturing, engineering, validation, supply chain, and others to

Qualifications

• BSc in engineering, life sciences, chemistry, QA, regulatory affairs, or a related discipline.
• Minimum five years of experience in the medical device, IVD, pharmaceutical, biotechnology, or a similar regulated industry.
• Experience leading CAPAs, root cause analyses, and QMS improvements.
• Ability to work independently/autonomously with overall responsibilities leading CAPAs
• Experience with QMS processes, including nonconformance, deviation, risk management, document control, training, and change control.
• Experience supporting internal and external audits.
• Working knowledge of ISO 13485 and applicable medical device regulations.
• Experience with eQMS and Microsoft Office applications.

Responsibilities

• Lead the CAPA program from initiation through closure, including action planning, effectiveness verification, performance monitoring, escalation, governance reporting, and guidance to cross-functional teams.
• Support the implementation, maintenance, and improvement of the QMS, including development and training of procedures, work instructions, forms, and related documentation.
• Ensure quality records and documentation are complete, accurate, compliant, and maintained in accordance with applicable procedures and record retention requirements.
• Analyze and report quality system data, trends, and investigation results to identify risks, support management review, and drive sustainable improvements.
• Serve as a Quality specialist supporting manufacturing, engineering, validation, supply chain, technical operations, and other product realization functions.
• Provide Quality oversight and support for nonconforming product investigations, deviations, change controls, risk assessments, validation activities, product disposition decisions, and continuous improvement initiatives.
• Support containment activities, impact assessments, and investigations associated with significant product quality, patient safety, or regulatory compliance concerns.
• Support internal audits, supplier audits, customer audits, regulatory inspections, and certification audits.

Skills

CAPA leadership

QMS improvements

Independent work

Audits

Documentation

MS Office

Education

BSc in engineering, life sciences, chemistry, QA, regulatory affairs, or related

Tools

eQMS

MS Office

Job description

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality. We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Senior Quality Assurance Specialist

Position Overview

The Senior QA Specialist leads CAPA activities and supports the QMS and site Quality Operations. The role investigates, escalates, resolves, and prevents quality issues while ensuring regulatory and procedural compliance. The position leads complex investigations, monitors QMS performance and trends, supports quality governance, and drives improvement. It works across functions to ensure products, processes, and quality systems meet requirements. Reporting to the Manager, QA Operations, the Senior QA Specialist provides technical leadership and guidance across site Quality Systems and operations to support compliance, inspection readiness, issue prevention, and sustainable improvement.

Responsibilities

• Lead the CAPA program from initiation through closure, including action planning, effectiveness verification, performance monitoring, escalation, governance reporting, and guidance to cross-functional teams.

• Support the implementation, maintenance, and improvement of the QMS, including development and training of procedures, work instructions, forms, and related documentation.

• Ensure quality records and documentation are complete, accurate, compliant, and maintained in accordance with applicable procedures and record retention requirements.

• Analyze and report quality system data, trends, and investigation results to identify risks, support management review, and drive sustainable improvements.

• Serve as a Quality specialist supporting manufacturing, engineering, validation, supply chain, technical operations, and other product realization functions.

• Provide Quality oversight and support for nonconforming product investigations, deviations, change controls, risk assessments, validation activities, product disposition decisions, and continuous improvement initiatives.

• Support containment activities, impact assessments, and investigations associated with significant product quality, patient safety, or regulatory compliance concerns.

• Support internal audits, supplier audits, customer audits, regulatory inspections, and certification audits.

Required Knowledge/Skills, Education, and Experience

• BSc in engineering, life sciences, chemistry, QA, regulatory affairs, or a related discipline.

• Minimum five years of experience in the medical device, IVD, pharmaceutical, biotechnology, or a similar regulated industry.

• Experience leading CAPAs, root cause analyses, and QMS improvements.

• Ability to work independently/autonomously with overall responsibilities leading CAPAs

• Experience with QMS processes, including nonconformance, deviation, risk management, document control, training, and change control.

• Experience supporting internal and external audits.

• Working knowledge of ISO 13485 and applicable medical device regulations.

• Experience with eQMS and Microsoft Office applications.

Preferred Knowledge/Skills, Education, and Experience

• Quality-related certifications or training such as ASQ Certified Quality Auditor (CQA), Certified Quality Engineer (CQE), Lean, Six Sigma, or Internal Auditor certification.

Who we are:

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work:

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers’ businesses, please visit our company page at Siemens Healthineers Canada.

The expected compensation for this position is:

$73,000 - $104,500

Factors which may affect starting compensation within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Siemens Healthineers offers a variety of health and wellness benefits including a flexible benefits plan, Defined Contribution Pension Plan, Registered Retirement Savings Plan matching contributions, plus a competitive paid time off program including vacation, company holidays, sick leave, and parental leave (all subject to eligibility requirements).

Equal Employment Opportunity Statement:

Siemens Healthineers is committed to creating a diverse environment and is proud to be an equal opportunity employer. While we appreciate all applications we receive, we advise that only candidates under consideration will be contacted.

Accessibility:

Siemens Healthineers is committed to excellence in serving all employees and customers, including people with disabilities. Siemens Healthineers will strive to ensure that policies and procedures established with respect to the provisions of its goods and services to persons with disabilities are consistent with the principles of dignity, independence, integration and equal opportunity as provided in the Accessibilities for Ontarians with Disabilities Act, 2005. Siemens Healthineers will continue to attempt to meet the needs of all its customers, including but not limited to persons with disabilities, in an effective and timely manner.

If you require a reasonable accommodation in completing a job application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please fill out the accommodations form here. If you’re unable to complete the form, you can reach out to our HR People Connect People Contact Center for support at [e-mail]. Please note HR People Connect People Contact Center will not have visibility of your application or interview status.

Data Privacy:

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open.

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To all recruitment agencies:

Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resumes.