Senior QA Specialist — CAPA & QMS Lead

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 drive improvements across manufacturing, engineering, and validation functions.

You will investigate, escalate, and prevent quality issues, ensuring regulatory compliance and effective governance across the site, with collaboration across cross-functional teams.

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.

Job description

Siemens Healthineers Canada is seeking a Senior Quality Assurance Specialist to lead CAPA activities, support the QMS and site Quality Operations, and drive improvements across manufacturing, engineering, and validation functions.

You will investigate, escalate, and prevent quality issues, ensuring regulatory compliance and effective governance across the site, with collaboration across cross-functional teams.