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Quality Assurance Expert

2 weeks ago

Markham, Ontario, Canada Microart Services Full time

About Microart Services

We are an electronic manufacturing company with a focus on producing high-quality Printed Circuit Boards (PCBs). Our commitment to quality and customer satisfaction has earned us strong, stable growth over 40 successful years and many valued long-term partnerships.

Job Description:

We are seeking a Quality Systems Specialist to join our team. As a key member of our Quality Management department, you will be responsible for monitoring and maintaining/updating applicable procedures, work instructions, and controlled documents of our Quality Management System (QMS).

Key Responsibilities:

  • Monitor and maintain/updating applicable procedures, work instructions, and controlled documents of the company QMS.
  • Assist and stay up to date with Quality and Regulatory compliance.
  • Conduct Internal Quality Audits across company sites and support the audit program.
  • Review and analyze data and company metrics/KPI for continuous improvement.
  • Participate in risk management activities and risk mitigation implementation in products and processes.
  • Monitor and evaluate suppliers, supplier quality issues, and supplier performance; Provide support for the supplier management program including supplier audits.
  • Perform product inspections to specified requirements and/or IPC standards.
  • Participate in documentation and investigation activities related to customer complaints.
  • Perform process and software validation activities.
  • Provide preparation and support for on-site management review meetings.
  • Assist during external ISO (Registrar) audits and regulatory inspections.

Qualifications:

  • Minimum 3 years' electronics manufacturing environment or medical device experience with strong quality auditing skills.
  • University degree, preferably in engineering or sciences with Quality Assurance background.
  • Knowledge of device regulations and its applications such as International Standards, FDA i.e. ISO 9001:2015, AS9100D, ISO 13485:2016.
  • Excellent knowledge of MS Office applications (Excel, PowerPoint, Word, Visio, etc.).
  • Ability to read, analyze, and interpret documents.
  • Ability to write well and effectively communicate.
  • Organized and attention to details.
  • Able to prioritize responsibilities and multi-task.