Senior Quality Assurance Engineer

22 hours ago

Cambridge, Ontario, Canada ATS Automation Full time
Job Description

ATS Automation is seeking a highly skilled Senior Quality Engineering professional to join our Life Sciences team. As a key member of our quality team, you will be responsible for ensuring the highest standards of quality in our products and processes.

Key Responsibilities:
  • Develop and implement quality processes and procedures to ensure compliance with regulatory requirements and industry standards.
  • Analyze customer-specific quality requirements and develop gap analyses to identify areas for improvement.
  • Lead or participate in internal audits and quality system assessments to ensure compliance with ISO 9001 and ISO 13485 requirements.
  • Provide mentoring and training to junior quality engineers and support the development of quality engineering processes and procedures.
  • Collaborate with cross-functional teams to identify and implement process improvements and ensure customer satisfaction.
Requirements:
  • 10+ years of experience in a manufacturing environment, preferably in the medical industry.
  • Working knowledge of ISO 9001 and ISO 13485 requirements, as well as FDA 21CFR820.
  • Hands-on experience with measurement techniques and tooling, as well as CMM programming.
  • Strong problem-solving skills, attention to detail, and excellent communication skills.
  • Ability to work independently and as part of a cross-functional team.
What We Offer:
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and inclusive work environment.
  • Recognition and rewards for outstanding performance.

ATS Automation is an equal opportunities employer and welcomes applications from diverse candidates. If you are a motivated and experienced quality professional looking for a new challenge, please submit your application today.

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