Position Title: Quality Manager
Position Type: Full-time, permanent, salary
Location: Cambridge, Ontario
Parent company PRIMED Medical Products Inc. (“PRIMED”) is a leading designer, manufacturer and marketer of single-use medical products to customers worldwide. PRIMED is proud to be an ISO 13485:2016 registered company and recognized as one of Canada’s 100 Best Managed Companies. The company has its corporate head office in Edmonton, international operations, four wholly-owned manufacturing facilities in Asia, and our newest facility in Cambridge, Ontario. PRIMED Cambridge joins the organization as the domestic production hub and Centre of Excellence for North American personal protective equipment production.
Reporting to the Plant Manager, you will lead quality and auditing activities. You will need to use exceptional creative problem solving and process improvement skills to analyze various systems and conduct statistical analysis to determine process capabilities. We are looking for a motivated individual who has a willingness to grow and develop with PRIMED.
Not only are they detail oriented, they will compile, calculate, and analyze quality statistics, perform finished goods audit and be a primary audit lead. By actively performing, monitoring, and training in the various inspection roles, the QC Manager will be an active participant in production of products and continuing to improve and optimize PRIMED’s world class quality.
The following is a list of the high-level activities or deliverables with the goal to maximize quality and reduce waste to the manufacturing line through process efficiencies:
- This position will be the Quality Management Representative for the plant.
- Ensures that all practices, procedures, and criteria at the plant meet or exceed the standards of the Plant’s QMS, ISO 13485 and Regulatory Requirements.
- This position works collaboratively with customers, corporate personnel, and plant personnel to develop and implement improvements to our quality assurance programs, procedures, and practices. The incumbent works with other plant management to ensure only the highest quality product is produced and shipped to PRIMED’s customers.
- Review feedback to identify potential product quality issues and implement effective corrective and preventive actions as required.
- Actively participates in plant’s drive for continual improvements by using Six Sigma, 5S and Lean Manufacturing expertise and tools.
- Maintain and enhance company quality standards
- Perform finished goods audit according to inspection protocols and sampling procedures
- Inspection and testing of raw materials, work in process, finished goods to ensure adherence to quality standards and product specifications
- Document evidence of the manufacturing process to ensure continued quality
- Lead functional area responses to CAPA and NCR
- Participate in production meetings with the manufacturing team
- Continuously review processes, systems and products to determine where improvements can be made including periodic inspections
- Review all test results and propose changes in specifications, materials, or products using evidence based analysis, as needed
- Follow all plant rules and safety regulations
- Ensure all Line Operators and QC Technicians are fully trained and certified
- Perform internal audits according to the QMS
- Support Plant Manager with special projects and work flow improvements, as required.
- An important part of the role is coaching and mentoring future leaders
- Must be legally eligible to work in Canada and be a minimum age of 18 years old
- ASQ or CQE Certified
- Minimum of 5 years’ experience in a Quality Manager role
- Experience in gauge calibration and maintenance an asset
- Well versed in the use of all Quality Tools and statistical analysis
- Experience in a Medical Device manufacturing environment is an asset
- Post-secondary education in Mechanical/Industrial/Quality Engineering or similar disciplines is preferred
- Demonstrated experience in LEAN, Six Sigma Certification
- A self-motivated individual who is willing to learn and grow with PRIMED.
- Able to work both independently with minimal supervision as well as in a team environment.
- Excellent written and verbal communication and with creative problem-solving skills
- Highly proficient in Microsoft Office with advanced knowledge in Excel
How to Apply
This position is available immediately. Interested applicants may submit their cover letter and resume in a single document via Indeed.
Due to the COVID-19 pandemic, responses to applicants may be delayed. We thank all applicants for their interest. Only those chosen for an interview will be contacted.
NOTE: This job posting is not intended to be all-inclusive. Employee may perform other related duties as required to meet the ongoing needs of the organization