Job Description
MAJOR DUTIES :
Responsible for the operation of quality processes, applications and analysis of data using statistical methods to diagnose and correct non-compliance situations.
Develop and administer data information systems and audit quality systems for deficiency identification and correction requirements in conjunction with other business disciplines using a cross-functional approach.
GENERAL RESPONSIBILITIES
- Ensure that all business activities are performed with highest ethical standards and in compliance with ATS code of business conduct.
- Adhere to all Health and Safety rules and procedures.
- Comply with all ATS Policies / Procedures / Instructions as per the ATS Quality Systems.
- Ensure that all business activities are performed in accordance with the ATS Confidentiality Policy.
- Lead or Participate in Continual Improvement Activities
SPECIFIC RESPONSIBILITIES :
- Analyze and report data used to monitor quality performance to ensure customer requirements are met.
- If applicable, conduct training of personnel with regards to internal procedures.
- Prepare Control Plans, and support update of Procedures or Checklists as applicable.
- Co-ordinate 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. Initiate Customer Initial Complaint Notifications (CICN) as appropriate.
- Act as a facilitator, as well as a team member for corrective action or 8D activities.
- Conduct internal product, process and procedure compliance audits, as appropriate.
- Maintain good relationships with all 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
- Support program launch and FAT activities.
- Support the Implementation as required of error proofing initiatives based on trend analysis perform on long term programs.
- Perform other duties as related to those outlined above, or which may be completed based on individual skill or experience.
Additional Information
QUALIFICATIONS : Education :
Education :
Graduate Engineer or Technologist or equivalent work experience (4 years min.)
ASQ CQE certification preferred
Experience :
- Five (5) years’ experience in a manufacturing environment
- 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.
- 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
30+ days ago