Senior Quality Assurance Engineer

6 days ago

Cambridge, Ontario, Canada ATS Automation Full time
Job Summary

We are seeking a highly skilled Senior Quality Assurance Engineer to join our team at ATS Automation. As a key member of our Quality Assurance department, you will be responsible for ensuring the highest level of quality in our products and services.

Key Responsibilities
  • Develop and implement quality processes and procedures to ensure compliance with regulatory requirements and company standards.
  • Analyze customer-specific quality requirements and develop gap analyses to identify areas for improvement.
  • Provide mentoring and training to junior quality engineers and other team members.
  • Lead or participate in internal audits and quality system assessments.
  • Collaborate with cross-functional teams to identify and implement process improvements.
  • Develop and maintain quality metrics and reports to track performance and identify areas for improvement.
  • Investigate and resolve quality issues and non-conformities.
  • Develop and implement corrective action plans to address quality issues.
  • Provide input and suggestions for internal quality and operational process improvements.
Requirements
  • Graduate degree in Engineering or a related field, or equivalent work experience.
  • Minimum 10 years of experience in a manufacturing environment, preferably in the medical industry.
  • Working knowledge of ISO 9001 and ISO 13485 requirements.
  • Working knowledge of FDA 21CFR820 is considered an asset.
  • Hands-on working knowledge of measurement techniques and tooling.
  • Able to read and understand CMM reports.
  • Able to read and understand Engineering drawings.
  • Training in GDP and GMP.
  • Demonstrated ability to work independently and to manage multiple projects from various diverse organizations.
  • Lean and/or Six Sigma Experience is an asset.
  • Strong problem-solving skills.
  • Ability to work as part of a cross-functional team.
  • Understanding of change management principles and Change Agent Skills.
  • Microsoft Excel, Word, PowerPoint – Intermediate level.
  • Current trained Internal ISO Auditor is considered an asset.
  • Highly developed attention to detail.
  • Excellent verbal and written communication skills.
  • Excellent reading comprehension.
  • Proficient at Blueprint reading.
  • Capable of performing basic measurements using hand tools is required, CMM programming capability (PC-DMIS or CMM Manager) is an asset.
What We Offer
  • Competitive salary and benefits package.
  • Opportunities for professional growth and development.
  • A dynamic and collaborative work environment.
  • A commitment to diversity and inclusion.
  • A comprehensive total rewards package.

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