Senior QA Specialist: CAPA & QMS Leader

Siemens Healthineers AG; Canada; On-site; CAD 104,000 - 148,000; Full time

Job summary

Siemens Healthineers is seeking a Senior Quality Assurance Specialist to lead CAPA activities, support QMS operations, and drive regulatory compliance across site Quality Systems. You will work across functions to ensure products, processes, and quality systems meet requirements.

Reporting to the Manager, QA Operations, you will provide technical leadership, develop procedures, and guide cross-functional teams in investigations, risk assessments, and continuous improvement initiatives.

Qualifications

• 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

Root cause analysis

QMS improvements

Audit support

Regulatory knowledge

Education

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

Tools

eQMS

MS Office

Job description

Siemens Healthineers is seeking a Senior Quality Assurance Specialist to lead CAPA activities, support QMS operations, and drive regulatory compliance across site Quality Systems. You will work across functions to ensure products, processes, and quality systems meet requirements.

Reporting to the Manager, QA Operations, you will provide technical leadership, develop procedures, and guide cross-functional teams in investigations, risk assessments, and continuous improvement initiatives.