Quality Manager, Production

PulseMedica; Mississauga; Hybrid; CAD 110,000 - 140,000; Full time

Benefits offered by this job

RRSP matching

Medical benefits

Job summary

Profound Medical is seeking a Quality Manager, Production to establish and maintain quality management systems ensuring products and processes meet applicable regulations. This role leads QC/QA activities across receiving, manufacturing, testing, and release.

The ideal candidate has 7–10 years of medical device experience, strong knowledge of FDA QSR, MDSAP, ISO 13485 and ISO 14971, and a track record of CAPA and audits. Excellent communication and data analytics skills are essential.

Qualifications

• Minimum 7-10 years medical device experience.
• Strong knowledge of device regulations (FDA QSR, MDSAP, ISO 13485, ISO 14971; EU MDR; CMDR).
• Ability to read, analyze and interpret common business documents; communicate effectively.

Responsibilities

• Lead QA/QC activities to ensure product release compliant with regulatory requirements.
• Oversee incoming, in-process and final inspections and testing.
• Manage DHR/Batch records and release decisions per specifications.
• Coordinate with Manufacturing, R&D, and Regulatory Affairs on audits and CAPA.
• Ensure calibration and traceability of inspection/test equipment.

Skills

Data analytics

Power BI

Communication skills

Problem solving

Independent worker

Education

Bachelor's degree in science or engineering

Tools

Microsoft Office

Excel

PowerPoint

Visio

Word

Job description

Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with minimal side effects.

If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.

General Accountability

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.

Duties and 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:
  1. ISO 13485:2016
  2. FDA 21 CFR Part 820 / QMSR
  3. EU MDR (if applicable)
  4. 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:
  1. Inspection procedures and test methods
  2. Test method validation/verification (IQ/OQ/PQ where applicable)
• Ensure appropriate use of:
  1. Functional testing
  2. Electrical safety testing (e.g., IEC 60601)
  3. Software verification checks
  4. 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.

Education & Certifications

• A minimum of a bachelor’s degree in science or engineering field.
• ASQ Certification in Quality management, Lean Six Sigma, Auditor or P.Eng.

Key Attributes

• 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.

We thank you for your interest in Profound Medical. Please note only candidates that are short-listed will be contacted.

The expected annual salary range for this role is $110,000-$140,000 CAD. Actual compensation will be determined based on experience, qualifications, and job-related factors. This role may also be eligible for participation in the company’s benefits programs, such as a group RRSP and medical benefits paid by the employer.

We strive to promote diversity and equal opportunity in the workplace and encourage applications from all qualified individuals, including those with disabilities. If selected to participate in the recruitment, selection, and/or assessment process, please inform Human Resources of the nature of any accommodation(s) that you may require.