Quality Engineer II

Excelitas Technologies•Mississauga, ON

14d•Onsite

About The Position

The Quality Engineer II will assist and support the Quality team with the implementation and maintenance of QMS for medical devices, specifically FDA 21 CFR Part 820 and ISO13485. Build relationship with existing suppliers to ensure compliance to the applicable regulations and standards 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. Learn about the quality engineering activities and apply it to the continuous improvement of our operations both internally and externally to reduce the impact of product non-conformances overall.

Requirements

3-6 years’ experience in a Medical Device Quality Assurance environment
Hands-on working experience with ISO 13485, FDA 21 CFR Part 820 and ISO14971 is required.
Solid understanding of root cause analysis and experience managing effective CAPA program.
Bachelor’s degree in a related engineering field. (mechanical or electrical/electronic preferred).
Internal or lead auditor in ISO13485 (ISO 9001 lead auditor is desired).
ASQ CQE and ASQ CSQP desirable.
Experience managing and performing both internal and external QMS audits.
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.
Knowledge of various quality system methodologies (8D, Six Sigma, FMEA, PPAP, etc.) is required.
Strong communication, presentation, and team building skills.
Manages time effectively, remains organized in all circumstances.
Self-motivated with a high level of initiative.
Excellent English verbal and written communication skills
Strong critical thinking, problem solving, and organizational skills
Experience in dealing with FDA and other related regulatory bodies' audit is a plus
Must be able to travel for business purposes

Nice To Haves

ISO 9001 lead auditor
ASQ CQE
ASQ CSQP
Knowledge of GD&T
Knowledge of CMM
Familiarity with Minitab
Experience in dealing with FDA and other related regulatory bodies' audit

Responsibilities

Perform supplier QMS audits, analyze trend of audit observations and present trend analysis data on a regular basis or periodically. Manage Supplier QMS audit program.
Perform Internal QMS audits.
Regularly communicate with Engineering, Manufacturing Engineering, and Supply Chain team members internally to identify opportunities for quality and productivity improvement.
Review supplier manufacturing processes, collaborate with suppliers on process improvement, and value enhancement opportunities.
Analyze and present supplier performance data on a regular basis.
Manage the overall supplier corrective action (SCAR) program.
Advise and support Quality Inspectors on day-to-day production issues and process controls.
Perform Scrap data analysis and implement program/quality plans to reduce scrap.
Participate in Engineering Change/design review meetings to ensure awareness to design changes, implement engineering changes in accordance with QMS requirements.
Implement and manage effective in-process and outgoing inspection program to meet and exceed customer expectations.
Develop relationships with the Purchasing, Manufacturing Engineering, Research & Development, and external suppliers in order to ensure product and material performance is adequately monitored, and, where problems occur, support appropriate and timely root cause analysis to ensure corrective actions are implemented as required.
Review inspection documents for First Article Inspection, incoming parts/materials, product in process, and outgoing product.
Address in-process quality issues in a timely manner to ensure continuity of production and supply.
Support senior QA team in the evaluation and approval of 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.
Maintain detailed reports on supplier quality, including defect rates and areas that result in flaws.
Support and assist the CAPA program, calibration program, deviation, change order processes as required.
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).
Utilize SPC tools to track and monitor key process stability and capability.
Other duties as assigned.