Role overview

Position Summary

Nivantis Corp is seeking an experienced Quality Manager to own and continuously improve our Quality Management System (QMS). This role is responsible for maintaining compliance with ISO 13485, IEC 60601, MDSAP, and Health Canada Medical Device Licensing (MDL) requirements, and for administering our electronic Quality Management System (eQMS) software. The Quality Manager will serve as the company's primary point of contact for quality and regulatory audits, and will partner closely with Engineering, Regulatory Affairs, Manufacturing, and Product Development to ensure product safety, compliance, and quality throughout the product lifecycle.

Key Responsibilities

Quality Management System

· Own the QMS end-to-end:maintain, audit, and continuously improve procedures, work instructions, and records to ensure ongoing conformance with ISO 13485:2016.

· Lead internal audits and coordinate external audits (notified body, MDSAP, Health Canada) to maintain certification status and drive corrective action closure.

· Manage the CAPA process, including root cause investigation, effectiveness checks, and trend analysis across complaints, nonconformances, and audit findings.

· Oversee document control and change management within the QMS, ensuring controlled documents remain current, approved, and accessible.

· Lead management review meetings and report quality metrics, KPIs, and risk indicators to senior leadership.

Regulatory Standards & Compliance

· ISO 13485:Serve as subject matter expert and system owner for the medical device QMS standard, ensuring all processes remain audit-ready.

· IEC 60601:Coordinate with engineering to ensure electrical medical equipment safety and EMC testing, documentation, and design verification/validation activities meet applicable IEC 60601 series requirements.

· MDSAP:Maintain Medical Device Single Audit Program compliance across participating jurisdictions (including the U.S., Canada, Australia, Brazil, and Japan), and lead preparation for MDSAP audit cycles.

· Health Canada MDL:Manage the company's Medical Device License(s), including license applications, amendments, renewals, and post-market compliance obligations under the Canadian Medical Devices Regulations (CMDR).

· Risk Management:Support ISO 14971 risk management activities in coordination with product development and engineering teams.

eQMS Administration

· Serve as system administrator for the company's eQMS software, managing user access, workflows, document repositories, and configuration.

· Maintain electronic records for document control, training, CAPA, audits, complaints, and change control within the eQMS.

· Train employees on eQMS use and ensure adoption of electronic workflows in place of manual/paper-based processes.

· Evaluate and implement eQMS enhancements, integrations, and upgrades to improve efficiency and audit readiness.

Supplier & Product Quality

· Manage supplier quality processes, including supplier qualification, audits, and scorecards.

· Support design control activities and design history file (DHF) maintenance.

· Investigate product complaints and support Medical Device Reporting (MDR) / vigilance reporting obligations as needed.

Qualifications

· Bachelor's degree in Engineering, Life Sciences, or a related technical field.

· 5+ years of quality management experience in the medical device industry.

· Demonstrated working knowledge of ISO 13485, IEC 60601, MDSAP, and Health Canada MDL/CMDR requirements.

· Hands-on experience administering eQMS software (e.g., MasterControl, Greenlight Guru, Veeva QMS, ETQ, or similar).

· Experience leading or hosting regulatory and notified body audits.

· Familiarity with ISO 14971 risk management principles.

· Strong analytical, organizational, and cross-functional leadership skills.

· Excellent written and verbal communication skills.

Preferred Qualifications

· Certified Lead Auditor (ISO 13485).

· Experience with MDSAP audit cycles as an auditee.

· ASQ certification (CQM, CQA, or CBA).