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Excelitas is a global technology leader with more than 7,500 employees, focused on delivering market-driven solutions to fulfill the illumination, optical, detection and imaging needs of OEMs and end-users across the biomedical, semiconductor, industrial, consumer products, scientific, security, defense and aerospace sectors.

ENGAGE with us today and make your contribution to the future! Join the team that leading technology companies turn to for cutting-edge photonic innovation. At Excelitas Technologies you are how we EXCEL.

Our facility in Mississauga, Ontario has key positions in Sales, Marketing, Research & Development, Engineering, Manufacturing, Customer Support and other disciplines. Operating since 1984, this site specializes in the design, development, manufacturing and marketing of a broad portfolio of innovative LED and Lamp technology. The Toronto facility serves a variety of markets such as electronics, optoelectronics, digital printing, general assembly, coatings, and medical device manufacturing, as well as endoscopy, bioscience research, microscopy and instrumentation.

We are presently seeking are seeking a Quality Engineer II who will assist the Quality team with the implementation and maintenance of QMS for medical devices, specifically FDA 21 CFR Part 820 and ISO13485. The incumbent will work with suppliers to assure 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. 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.

Main 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, calibration program, deviation, DCO, and ECO processes.
• 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).
• Perform internal and external quality audits.
• Utilize SPC tools to track and monitor key process stability and capability.
• Other duties as assigned.

Requirements:

• 3-5 years’ experience in a Quality Assurance environment, hands-on working experience with ISO 13485, FDA 21 CFR Part 820 and ISO14971 is required.
• College level or higher technical degree (mechanical or electrical/electronic preferred).
• 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.
• Knowledge of various quality system methodologies (8D, Six Sigma, FMEA, PPAP, etc.) is preferred.
• Excellent English verbal and written communication skills.
• Strong critical thinking, problem solving, and organizational skills.
• Understanding of project management principles is an asset.
• Experience in dealing with FDA and other related regulatory bodies' audit is a requirement.

Equal Opportunity/Affirmative Action Employer

Minorities/Females/Disability/Gender Identity/Sexual Orientation

Excelitas is seeking leaders and innovators to join our global team! Visit: www.excelitas.com/join-our-team