Quality Assurance Specialist

Teledyne Micralyne Inc. is internationally recognized for its unique design and fabrication in Micro Electromechanical Systems (MEMS) technology. With over 30 years of experience and business, Teledyne Micralyne is leading today’s cutting-edge MEMS technology in Canada. Every member of the Teledyne Micralyne team is committed to the following core values: Innovation, Excellence, Integrity and Commitment. Teledyne Micralyne is proud to work with customers as strategic partners towards providing innovative solutions to meet evolving global needs and societal expectations. Teledyne Micralyne is the heart of devices that advance humanity.

ISO9001:2015 and ISO13485:2016 certified.

Summary

The Quality Assurance Specialist is responsible for the execution and management of the quality management system (QMS).  While performing the various QMS procedures interaction will be required with suppliers, internal, and external customers communicating on a variety of topics concerning material, process, and product issues.  This interaction with the various parties will need to be timely and detailed.

Duties & Responsibilities

• Interact with customers to resolve issues and communicate any agreement requirements
• Participate in design and gate reviews to ensure all customer specifications and requirements are accurate and controlled
• Work with internal departments and suppliers to procure suitable material and ensure material meets expectation
• Implement design for manufacturability throughout the product life cycle
• Certify outgoing products conform to device requirements and devices are cleared to ship
• Execute, maintain, and update various quality systems, factoring in many considerations to ensure requirements are met
• Ensure policies and procedures abide by ISO and regulatory requirements
• Ensure that manufacturing records are complete and that procedures conform to established standards, controlled documentation, and regulatory requirements
• Co-ordinate corrective and preventative activities
• Manage/lead internal and external quality audits
• Provide timely and regular reporting as required
• Provide training and mentorship of the quality procedures

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience

• Bachelor’s Degree in Engineering or Diploma in Engineering Technologies (required)
• 3+ years in a quality control or quality assurance role in a manufacturing environment (required)
• Certification in Understanding & Implementing ISO 9001/13485 (preferred)
• Certification in ISO 9001/13485 Internal Audit (preferred)
• Experience working with medical devices and medical regulatory bodies (preferred)
• Experience working in a fabrication/clean room environment for semiconductor or MEMs (preferred)

Apply for this position