Location: Ontario, Canada

Employment Type: Full-Time

Schedule: Monday to Friday, 8-hour shifts

Vacancy Type: New Position

Salary Range: $55,000 – $70,000 per year

Company Description

Nanz Pharma is a globally respected pharmaceutical company with a strong focus on innovation, excellence, and accountability to customers, partners, employees, and communities. The organization specializes in the manufacturing of Natural Health Products (NHPs) and operates across the pharmaceutical, medical device, and healthcare sectors, delivering high-quality products and solutions that improve quality of life and meet global standards. Nanz Pharma is committed to developing hygiene and wellness products while expanding its capabilities in pharmaceutical manufacturing and medical device-related businesses.

Guided by its vision to provide high-quality products at affordable prices, the company is built on the principles of trust, quality, and brilliance. Nanz Pharma offers a dynamic workplace for professionals who are passionate about contributing to meaningful healthcare solutions and supporting the organization's long-term global growth.

Position Summary The Quality Systems & Compliance Specialist is responsible for supporting and strengthening the Quality Management System (QMS) to ensure compliance with applicable regulatory requirements, quality standards, and company procedures. This role supports the global commercialization and distribution of medical devices while providing quality oversight for GMP-regulated operations, including Natural Health Products (NHPs). The successful candidate will collaborate across multiple functions to maintain regulatory compliance, support inspection readiness, enhance quality systems, and drive continuous improvement in a rapidly growing and highly regulated environment.

Key Responsibilities

- Support compliance with ISO 13485, MDSAP, Health Canada, FDA, GMP, and other applicable international regulatory and quality system requirements.
- Support the maintenance, administration, and continuous improvement of the Quality Management System (QMS) in accordance with applicable regulatory requirements, industry standards, and company procedures.
- Manage document control activities including creation, revision, approval, issuance, archival, retention,



and maintenance of controlled documents and quality records.
- Review and maintain medical device technical documentation, quality records, traceability documentation, specifications, and product lifecycle documentation.
- Participate in quality activities supporting global medical device registrations, market expansion initiatives, distributor qualification programs, and regulatory compliance requirements.
- Support complaint handling, post-market surveillance, adverse event assessments, customer feedback investigations, trending, and associated CAPA activities.
- Coordinate and track quality system processes including deviations, non-conformances, change controls, corrective and preventive actions (CAPAs), risk assessments, and effectiveness reviews.
- Review manufacturing, packaging, testing, and product release documentation to ensure completeness, accuracy, compliance, and data integrity.
- Support supplier qualification, vendor certification, quality agreements, supplier performance monitoring, supplier audits, and supplier corrective action programs.
- Participate in qualification and ongoing oversight of distributors, contract manufacturers, laboratories, logistics providers, and external service partners.
- Support internal audits, supplier audits, customer audits, MDSAP audits, Health Canada inspections, FDA inspections, and other regulatory assessments, including audit preparation and follow-up activities.
- Perform quality-related ERP transactions associated with material status management, inventory controls, product disposition, quality holds, and release activities.
- Monitor quality metrics, regulatory compliance indicators, and performance trends to support management review and continuous improvement initiatives.
- Collaborate with Regulatory Affairs, Operations, Warehouse & Supply Chain, Maintenance & Engineering,



PMO and commercial teams to support product launches, process improvements, and compliance objectives.
- Contribute to the development of scalable quality systems, operational excellence initiatives, inspection readiness programs, and global quality compliance activities supporting business growth.

Key Requirements

- Bachelor's Degree or Diploma in Life Sciences, Biotechnology, Pharmaceutical Sciences, Chemistry, Engineering, Quality Assurance, Regulatory Affairs, or a related discipline.
- 5+ years of experience in a regulated healthcare environment, preferably within Medical Devices, NHPs, Pharmaceuticals, or related industries.

- Working knowledge of ISO 13485, MDSAP, Medical Device Quality Management Systems, and applicable Health Canada and FDA requirements is highly desirable.
- Experience with quality systems processes including CAPA, Change Control, Non-Conformance Management, Complaint Handling, Risk Management, Document Control, and Internal Auditing.

- Familiarity with medical device lifecycle documentation, post-market surveillance, supplier quality management, and regulatory inspection readiness activities.
- Proficiency with ERP systems, electronic Quality Management Systems (eQMS), and document management platforms.

- Strong communication, organizational, analytical, and problem-solving skills with the ability to collaborate effectively across global and cross-functional teams.

Core Competencies

MDSAP • ISO 13485 • Medical Devices • Health Canada • FDA • Quality Management Systems (QMS) • CAPA • Change Control • Risk Management • Post-Market Surveillance • Supplier Qualification • Vendor Certification • Distributor Qualification • Technical Documentation • Global Regulatory Compliance • Complaint Handling • Auditing • Data Integrity • ERP Systems • Continuous Improvement • Inspection Readiness • Global Supply Chain Quality • Operational Excellence

Hiring Process

- Human-led recruitment and selection process (no AI screening used)
- Candidates will be updated within 45 days of interview completion

Apply Now If you are detail-oriented, process-driven, and passionate about supply chain excellence, we encourage you to apply and join our growing team.

📌 Quality Systems & Compliance Specialist (Medical Devices & GMP Operations) (Pickering)
🏢 Nanz Pharma
📍 Pickering