Quality Assurance Engineer

4 days ago

Vaughan, Ontario, Canada J. Sterling Industries Full time

About J. Sterling Industries

We are a North American based contract manufacturer and assembler of medical devices and sub-components, delivering successful products to Fortune 100 OEMs and mid-size medical device OEMs.

Job Description:

We seek an experienced Quality Assurance Engineer to join our team. This role is responsible for launching and managing quality-related processes, ensuring compliance with regulatory requirements and company standards.

The ideal candidate will have a strong background in quality statistics, metrology, and biomedical technologies. A bachelor's degree in engineering, ISO 13485:2016 Auditor Training Certificate, and experience in a medical device OEM or contract manufacturer ISO registered environment are preferred.

Key Responsibilities:

  • Process Development: Develop and implement quality-related processes and documentation for new program development and current sustainment business.
  • Manufacturing Process Improvement: Direct involvement in manufacturing process development and continuous improvement to meet or exceed the company's quality metrics and process metrics.
  • Customer/Internal/Supplier Quality Issues: Review, analysis, and resolution of customer/internal/supplier quality issues through root cause analysis and implementation of corrective actions.
  • Preventative Actions and Continuous Improvements: Develop and implement preventative actions and continuous improvements within the manufacturing and quality areas.
  • Gage Equipment Management: Control of the non-conformance area (inventory, disposition, and associated costs), purchase, management, and review of gage equipment, certifications, and calibrations.
  • Daily Inspection and Approval: Coordinate with the quality inspector for the daily inspection, measurement, test, and approval of all components, product, process, and use of quality metrics to ensure quality targets are met.
  • Communication and Coordination: Communicate and coordinate with management, administrative, operations, quality, and engineering departments.
  • Quality Management System Software: Daily use of quality management system software and SPC systems.
  • Audits: Participate in conducting supplier and internal system and process audits.

Position Requirements:

  • Bachelor's Degree: Engineering degree with a background in quality statistics, metrology, biomedical technologies.
  • Experience: 3-5 years' experience in a quality department in a medical device OEM or contract manufacturer ISO registered environment.
  • Certifications: ISO 13485:2016 Auditor Training Certificate.

Salary Range: $80,000 - $110,000 per year.

This role requires excellent communication skills, attention to detail, and the ability to work in a fast-paced environment. Experience with machining, fabrication, and assembly operations is a plus. The position will require some travel (USA and Canada). Sterling Industries will consider and provide accommodations throughout the recruitment, selection and/or assessment process to applicants with disabilities.

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