Senior Quality Engineering

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. Responsible for assessing customer-specific Quality requirements versus current capabilities. Provide mentoring on Quality Engineering Processes and Procedures. 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 customer specific quality requirements. Develop a gap analysis against current capabilities and provide guidance of what is needed to close gaps.
•    Point of Contact for regulatory audits. I.e. TUV and UL/ULc
•    Provide input and suggestions for internal Quality and Operational process improvements
•    Provide mentoring and if applicable, conduct training of more junior Quality Engineering personnel
•    Perform external audits and witness testing at suppliers’ facilities as required
•    Perform trend analysis on Quality data and identify required corrective actions to ensure customer requirements are met.
•    Prepare Control Plans, and support update of Procedures or Checklists as applicable.
•    Co-ordinate Product FAI’s and verification of supplier parts.
•    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 per schedule.
•    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.
•    Support program launch and FAT activities.
•    Support the Implementation as required of error proofing initiatives based on trend analysis performed 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:
Graduate Engineer or Technologist or equivalent work experience (10 years min.)
ASQ CQE certification preferred

Experience:
•    Ten (10) years’ experience in a manufacturing environment preferably associated with the medical industry
•    Working knowledge of ISO 9001 and ISO 13485 requirements.  In depth understanding is considered an asset. 
•    Working knowledge of FDA 21CFR820 is considered an asset
•    Working knowledge of Automation and / or Medical Device industry quality requirements.
•    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