Quality Manager

2 weeks ago

Beamsville, Canada Span Medical Products Canada Full time

Span Medical Products Canada (SMPC) manufactures nursing home beds for the North American market and has been a supplier of medical devices for 104 years. Our facility of 95 associates is located in **Beamsville**, the heart of Ontario's wine producing region. SMPC produces beds using metal fabrication, welding, robotic welding, paint and assembly processes in our 50,000 square foot facility. We have a great team through all facets of the business and have a growth strategy that supports development of our people.

**We are currently recruiting for a Quality Manager to join our Beamsville team, reporting to the Director, Quality who is based in the U.S.**

The role of the Quality Manager is to champion all major components of the QMS including change control, process control, calibration, and CAPA through feedback. This position is responsible for maintaining an effective Quality Systems in accordance with Health Canada, FDA Quality Systems Regulation, applicable ISO standards and other applicable country-specific regulations. The Quality Manager works with engineering and manufacturing personnel to develop specifications, processes, and procedures that will ensure our products meet or exceed our customers’ expectations. Continuous improvement should be an output from the constant QMS PDCA feedback loop. Leads the Quality Specialists, Quality Technicians, and Quality Engineers in daily activities to support the above functions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

- Quality Management Representative for Span Medical Products Canada.
- Develop, implement, maintain and monitor quality metrics for the facility.
- Document quality systems and programs in quality trends, training, corrective and preventive actions, process control, customer complaints, etc. to ensure compliance with FDA, Health Canada, applicable ISO standards, and regulatory requirements.
- Ensure corrective actions implemented are effective by verifying that repeat failures are eliminated.
- Lead regulatory inspections and customer audits.
- Support the Internal Audit Program by participating in internal audits per the schedule and review the results of all audits to ensure the resolution of any noted deviations.
- Implement inspection/audit programs in manufacturing.
- Help ensure proper coordination and cooperation with supporting departments and regulatory bodies.
- Assist with employee development, coaching and performance management, as needed.
- Additional duties as requested or required.

ACCOUNTABILITIES:

- Interface with product development, manufacturing, process, and quality personnel as well as with Span America sales and marketing to determine product quality specifications.
- Integral part of the ECO process (regulatory requirements, process capability/control, quality plans, etc).
- Establish Process Control Plans and ensure conformance to regulatory requirements.
- Provide all necessary information concerning product parameters and inspection to production personnel.
- Set up proper instrumentation to measure and record variables and train employees on the proper use of the instruments.
- Evaluate processes and ensure they are capable of consistently meeting specification requirements
- Define attributes and set accept/reject parameters
- Assist in developing effective corrective actions to quality issues
- Assist with returned product investigations as needed to understand failure modes and actions required.
- Assist with handling customer complaints and service requests.
- Willing to travel to customers to resolve quality problems and build effective customer relationships.
- Develop and implement quality control standards and inspection procedures for receipt and control of incoming materials, in-process materials, final product acceptance activities and nonconforming materials.
- Establish and maintain test instrument calibration procedures and maintenance schedules
- Active participant in all stages of design development, ensuring quality assurance considerations and requirements met
- Should exhibit the ability to evaluate requirements for testability, design efficient test cases, and write extensive technical documentation
- Participate in the review of product requirements, design requirements, software requirements specifications, and functional specifications.

**Qualifications, Skills and Abilities**:

- Minimum BSc, Quality, Engineering or Mechatronics education or equivalent work experience required.
- Five to ten years of experience in Quality Assurance/Compliance, preferably in a managerial role.

Experience in medical device manufacturing, steel manufacturing, automotive or aeronautics industries preferred.
- Thorough knowledge of CGMP/FDA regulations, an asset.
- Experience with Regulatory Agencies Internal /Externals Audits programs.
- Very strong documentation management skills.
- Knowledge in the interpretation of engineering drawings, specifications and manufacturing process evaluation.
- Strong comp

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