Quality Manager, Production

Profound Medical•Mississauga, ON

1d•CA$110,000 - CA$140,000

About The Position

We are seeking a Quality Manager, Production who will be responsible for establishing and maintaining quality management systems to ensure products and process meet applicable regulations, requirements and specifications. Accountability includes the maintenance and improvement of the Quality Management System activities through Objectives & key results. This covers operations such as receiving/incoming, manufacturing, shipping, distribution and reverse logistics. This role plays a critical role in product safety, compliance, and batch/device release, working closely with QA, Manufacturing, R&D, and Regulatory Affairs. This role will lead inspection, testing, and release activities, ensuring compliance with MDSAP, ISO 13485, FDA QMSR (21 CFR Part 820), IEC standards, and applicable regulatory requirements.

Requirements

A minimum of a bachelor’s degree in science or engineering field.
ASQ Certification in Quality management, Lean Six Sigma, Auditor or P.Eng.
Minimum 7-10 years medical device experience; or equivalent combination of education and experience.
Strong knowledge of device regulations and its applications such as FDA QSR, International Standards i.e, MDSAP, ISO 13485, ISO 14971; EU Medical Device Regulation (MDR), and Canadian Medical Device Regulations (CMDR).
Language Skills: Ability to read, analyze and interpret common business documents. Ability to respond to common inquiries or complaints from customers, members of the business community.
Strong communication, problem- solving, and organizational skills;
Ability to work independently and in a team
Data analytics capability using statistical techniques and Power BI tools to make statistical inference.
Excellent knowledge of Microsoft Office applications such as Excel, Power point, Visio, Word, etc.

Responsibilities

Responsible for incoming, in-process, and final inspections to ensure product release is as per Medical Device File / Design Master File.
Support quality activities for products in production, in house and outsources.
Lead all incoming, in-process, and final inspection/testing activities
Ensure Device History Record (DHR) / Batch Record completeness, accuracy, and compliance before release
Oversee product release decisions (accept/reject) in accordance with specifications and regulatory requirements
Manage inspection plans, sampling strategies, and acceptance criteria (e.g., ANSI/ASQ Z1.4 and Z1.9)
Ensure QC processes comply with: ISO 13485:2016, FDA 21 CFR Part 820 / QMSR, EU MDR (if applicable), Relevant standards (e.g., IEC 60601, ISO 14971)
Support internal, customer, and regulatory audits and inspections
Maintain inspection and test records in compliance with data integrity (ALCOA+) principles
Approve and maintain: Inspection procedures and test methods, Test method validation/verification (IQ/OQ/PQ where applicable)
Ensure appropriate use of: Functional testing, Electrical safety testing (e.g., IEC 60601), Software verification checks
Oversee non-destructive and destructive testing protocols
Ensure incoming material inspection aligns with supplier quality agreements
Collaborate with Manufacturing Engineers/ Purchasing on Supplier performance issues and incoming defects / SCARs
Define and optimize receiving inspection strategies (including skip lot, risk-based approaches)
Manage nonconforming product identification, segregation, and disposition, and recalls
Participate in Root cause investigations (RCA) and CAPA activities
Ensure proper documentation of rework/repair in compliance with regulatory expectations
Evaluate impact of nonconformances on product safety and regulatory reporting
Ensure all inspection and test equipment are Calibrated and maintained and traceable to national/international standards
Other duties as assigned.