Quality Assurance Specialist
4 weeks ago
Job Title: Quality Assurance Specialist
Job Summary:
We are seeking a highly skilled Quality Assurance Specialist to join our team at ATS Automation. The successful candidate will be responsible for ensuring the highest quality standards are met in our manufacturing processes.
Key Responsibilities:
- Analyze and report data to monitor quality performance and ensure customer requirements are met.
- Conduct training of personnel on internal procedures.
- Prepare Control Plans and support updates of Procedures or Checklists as applicable.
- Coordinate Product FAI's and verification of supplier parts.
- Participate or lead external audits and witness testing at suppliers' facilities, if appropriate.
- Investigate product/process quality issues and initiate Customer Initial Complaint Notifications (CICN) as necessary.
- Act as a facilitator and team member for corrective action or 8D activities.
- Conduct internal product, process, and procedure compliance audits, as required.
- Maintain good relationships with functional groups and locations within the Company by participating in functional and multi-functional teams.
- Maintain good relationships and liaison with external customers and suppliers on Quality-related matters.
- Perform trend analysis on Quality data and identify required corrective actions.
Requirements:
- Graduate Engineer or Technologist or equivalent work experience (4 years min.).
- ASQ CQE certification preferred.
- Five (5) years' experience in a manufacturing environment.
- Demonstrated ability to work independently and 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.
- Working knowledge of ISO requirements – 9001 and 13485.
- Current trained Internal ISO Auditor is considered an asset.
- Highly developed attention to detail.
- Working knowledge of Automation and/or Medical Device industry quality requirements.
- Excellent verbal and written communication skills.
- Excellent reading comprehension.
- Proficient at Blueprint reading.
- Training in GDP and GMP.
- Knowledge of measurement techniques. Able to interpret CMM reports.
- Capable of performing basic measurements using hand tools is required, CMM programming capability is an asset.
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