Quality Engineer II

ENABLE your future through light.

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.

The Mississauga facility is an FDA registered Contract Medical Device Manufacturer.

We are currently seeking a Quality Engineer II who will assist and support the Quality team with the implementation and maintenance of QMS for medical devices, specifically ISO 13485, FDA 21 and CFR Part 820, and ISO 9001 Program.

Requirements:

• Perform and manage QMS audit program.
• Work as back up to overall Instrument Calibration and Preventive maintenance program.
• Regularly communicate with Engineering, Manufacturing Engineering, and Supply Chain team members internally to identify opportunities for quality and productivity improvement.
• Actively participate in engineering change/design review meetings to ensure awareness to design changes, implement engineering changes in accordance with QMS requirements.
• Train new internal auditors and periodic review of internal auditors’ performances.
• Actively support External Audits (Customer, Regulatory, Registrar).
• Support and manage CAPA program.
• Review supplier manufacturing processes, collaborate with suppliers on process improvement, and value enhancement opportunities.
• Analyze and present supplier performance data on a regular basis.
• Support and manage the overall supplier corrective action (SCAR) program.
• Implement and manage effective in-process and outgoing inspection program to meet and exceed customer expectations.
• Management of the customer complaint program.
• Develop relationships with the Purchasing, Manufacturing Engineering, R&D, and external suppliers in order to ensure product and material performance is adequatley 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.
• Other duties as assigned.
  
  

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.
  
  

Equal Opportunity/Affirmative Action Employer

Minorities/Females/Disability/Gender Identity/Sexual Orientation

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