Responsible for providing support and guidance to TMI staff in the area of metrology to ensure consistent, compliant, quality components for assembly into variations of medical devices. Provide metrology expertise to internal and external parties. And, developing and initiating measurement techniques and plans that support current and new development programs.
Responsibilities Include:
Quality Management
- Measurement Plans: control and approve measurement plans, including:
a. Verification of measurement technique
b. Documentation of measurement plan from template
c. Develop fixtures as necessary, working with external resources (suppliers)
d. Seek approval from suppliers for measurement plans
- Work with Quality Technologists to reduce variation between TMI and supplier measurements.
- Participate in product and program reviews by working with Product Development staff, exchanging information and statistical data
- Assist in the development of product drawings and the development of programs, documents and instructions for inspecting product
- Monitor and facilitate quality activities for part approval
- Control and approve inspection sheets developed by Inspectors
- Measure, or coordinate measurement of parts, for suppliers and Product Development staff as required
- Use quality tools and practices for analysis of data, e.g. 5 Why’s, root cause analysis, Pareto charts, etc.
- Prepare and distribute reports on data analysis
- Gauge Maintenance
a. Support calibration procedures as required
b. Lead or support calibration and gauge repeatability and reproducibility (GR&R), as required
c. Complete calibration documentation and maintenance, as required
d. Maintain GR&R records, as required
- Support validation activities of software and measurement systems in the Quality Assurance lab
- Coordinate inspection requests from New Product Development by ensuring full understanding of requirements and allocation of tasks to appropriate member of the Quality Department
Quality Compliance
- Ensure all products are assembled following Assembly Procedures, Standard Operating Procedures, Good Manufacturing Practices, and in accordance with the Quality Policy Objectives
- Review all production assembly records for accuracy, i.e. verify and sign shop floor orders
- Participate in the creation of quality plans for new products developed under design control
Quality Audits
- Participate in internal and external audits as required
a. Write audit reports
b. Issue corrective actions
Quality Issue Identification and Resolution
- Assist staff in various departments, e.g. Quality, Operations, Product Development, in identifying, communicating and resolving supplier quality problems through Inspection Requests and other requests
- Investigate, document and support the resolution to product quality related issues and concerns related to:
a. Product and process non-conformance reports (NCRs) –coordinate the resolution, e.g. test more components, involve TMI staff from applicable areas
b. Temporary deviations (TDs)
c. Internal corrective and preventative actions
Health and Safety
- Ensure compliance with relevant health and safety legislation, including the Workplace Safety and Insurance Act, the Occupational Health and Safety Act, etc.
Policy Compliance
- Adhere to all relevant policies, procedures and legislation
Supplementary
- Support incoming and in-process inspection if required, i.e. elevated demand (volume or timing) and limited staff resource availability:
a. Perform required incoming inspection with calibrated measurement equipment according to measurement plans
b. Perform in-process inspections leading to the release of components and finished goods as required
c. Complete/perform inspection requests
- Complete the quality portion of device history documentation for approval
- Participate in Quality Development programs with the focus on continuous improvement
- Prepare purchase requisitions as required
- Assist in the training of Quality Technologists and Inspectors
- Participate in cross-functional teams as a Quality representative
- Perform special projects as required
- Participate in ongoing training and professional associations as appropriate
- Fully utilize TMI resources to ensure delivery of a quality product to all internal and external customers at a minimal cost
Required Qualification:
Education & Experience
- University degree in engineering (mechanical engineering, biomedical mechanical engineering, or related field)
- Certified Quality Engineer (CQE) certification
Specialized Skill or Knowledge
- Strong metrology knowledge and applied experience in the development of measurement programs, i.e. must be able to work without supervision in this area
- Strong measurement system analysis experience
- Strong gauge repeatability and reproducibility experience
- Ability to read and interpret blueprints with geometric dimensioning and tolerancing (GD&T), through experience or education (e.g. college level blueprint reading course)
- Ability to develop, implement and verify measurement techniques and testing of products and processes
- Demonstrated ability to work in a close team environment
- Ability to safely lift 10-15 pounds on a regular basis
- Ability to safely lift 15-30 pounds on an occasional basis
- Knowledge of a quality system program is an asset
- General knowledge of Good Manufacturing Practices (GMPs) is an asset
- Basic math skills are assets
- Computer literacy including:
a. Intermediate experience in MS Word or comparable word processing software
b. Intermediate experience in MS Excel or comparable software
c. Intermediate experience in MS Outlook or comparable email and scheduling software
- Good knowledge of statistical and quality tools
- Ability to handle multiple projects at the same time with excellent follow up skills
- Effective interpersonal skills
- Excellent oral and written communication skills
- Ability to work independently
- Excellent organizational, analytical skills, especially in completing accurate and legible reports
- Able to accurately visually inspect small components
- Ability to travel internationally as required, i.e. valid Passport required