Mississauga, ON, Canada
This position will assist the Quality team with the implementation and maintenance of QMS for medical devices, specifically FDA 21 CFR Part 820, MDSAP and ISO13485. Work with suppliers to assure compliance to the applicable clauses of the Medical Device Regulations and reduce the impact of supplier related Line Fall Out on Operations, and by extension the reduction of related scrap and impact on warranty claims related to defective supplier products. This position will also be responsible for general quality engineering activities related to the continuous improvement of our operations both internally and externally to reduce the impact of product non-conformances overall.
Major Duties and Responsibilities
- Work with the QA team, Purchasing, Manufacturing Engineering, Research & Development, and external suppliers to ensure product and material performance is adequately monitored and where problems occur, appropriate and timely root cause analysis and corrective actions are implemented as required.
- Review and approve inspection documents for First Article Inspection, incoming parts/materials, product in process, and outgoing product. Support Quality Inspection function.
- Disposition and trend of non-conforming parts and product. Champion problem solving and root cause analysis activities with internal and external suppliers and customers to eliminate recurrence of non-conformances.
- Monitor, communicate, and improve key supplier performance criteria such as KPI's and CTQ's, including Supplier OTD (Past due), DPPM and scrap. Including supporting Purchasing in supplier's SCAR management.
- Address in-process quality issues in a timely manner to ensure continuity of production and supply. Engage QA. Purchasing, Production, R&D, and Product Management as required.
- Work with Purchasing and Production to evaluate and approve new suppliers and/or processes as part of the New Product Introduction process and/or full production products. Support production part approval process.
- Track supplier performance in an effort to increase supplier capability.
- Support CAPA process.
- Assure compliance to all applicable regulatory and legal requirements pertaining to the QMS like ISO 13485, FDA 21 CFR Part 820 and ISO 14971
- Participate in product realization process (including FMEA)
- Support deviation, DCO, ECO approval.
- Support calibration program.
- Perform internal and external quality audits.
- Utilize SPC tools to track and monitor key process stability and capability.
- College level technical degree (mechanical or electrical/electronic preferred).
- A minimum of 5 years' experience in a Quality Assurance environment, hands-on working experience with ISO 13485, FDA 21 CFR Part 820 and ISO14971 is required.
- Experience in dealing with FDA and other related regulatory bodies' audit is a requirement.
- Certified internal or Lead auditor in ISO13485, FDA 21CFR Part 820 and ISO14971 is a plus. Hands-on experience in conducting both internal and external audit.
- Must be able to interpret technical drawings, schematics, and specification sheets.
- Experience using test equipment such as: optical coordinate measuring machine, micrometer, caliper, pin gauges, digital multimeter, power supply, and oscilloscope.
- Knowledge of GD&T, and CMM is an asset.
- Advanced computer skills using Microsoft Office applications and relational databases. Familiarity with Minitab is an asset.
- Strong critical thinking, problem solving and organizational skills.
- Understanding of project management principles an asset.
- Knowledge of various quality system methodologies (8D, Six Sigma, FMEA, PPAP, etc. is preferred)
- Must have strong verbal and written communication skills, work well with diverse groups of people and be able to function independently of direct supervision.
- Must have a valid driver's license in good standing and the ability to travel for business purposes.