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Supplier Quality Engineering
3 months ago
The world isn’t standing still, and neither is ATS Life Sciences - We don’t follow the trends. We set them
Are you interested in being part of a team that makes a difference? Join our growing ATS Life Sciences Systems team a division of ATS Corporation, a publicly traded global enterprise with a proud history, we are helping advance the future with our factory-wide automation solutions. Within Life Sciences Systems, what we do matters – we custom design, build and service critical automated solutions for medical device and pharmaceutical companies. We are dedicated to assisting our customers in improving the quality of life for people around the world. When there is no room for error, and product failure is not an option, leading life sciences companies trust us to resolve their production challenges.
Job Description
Major Duties
Responsible for all quality improvement issues related to vendors and suppliers of materials, products or services used in the manufacturing of custom and build to print automation and assessing potential new suppliers based on ISO9001 and ISO13485 requirements.
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
Supplier Quality Engineering Responsibilities:
• Drive supplier quality performance, including new product development and product quality improvement, by monitoring KPIs, delivering and following up on supplier scorecards, and maintaining detailed reports / trending on defect rates and areas of concern
• Issue Supplier Corrective Actions and provide guidance on effective completion as necessary, following up through to completion.
• Ensuring the supplier meets all regulatory and company requirements including change management through ongoing supplier engagement and Quality System audits
• Maintain good relationships and liaison with external customers and suppliers on Quality related matters.
• Provide technical advice and guidance to suppliers to reduce defect rates.
• Support Supply Chain with Researching, sourcing, providing technical leadership, and assessing the vendors to supply parts and materials.
• Participate or lead external audits and witness testing at suppliers’ facilities, if appropriate.
• Visit vendor facilities to review and assess their manufacturing capabilities as necessary.
• Co-ordinate, review and approve FAI’s, deviations, process change notifications and corrective actions.
• Prepare Control Plans, and support update of Procedures or Checklists as applicable.
• Investigate product / process quality issues, drive improvements as necessary
• 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.
• Promote initiatives to improve quality
• 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.
• Support calibration activities as necessary
• Other duties as assigned
• Note: Must be able and willing to travel nationally and internationally when required.
Additional Information
Qualifications
Education:
• A bachelor's degree in engineering, or ASQ CQE certification, or equivalent technical aptitude and experience.
Experience:
• At least 5 years of Quality Assurance Engineering or Supplier Quality Engineering experience in a manufacturing and/or fabrication 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.
• In-depth knowledge of ISO9001 & ISO13485 is considered an asset.
• Current trained Internal ISO Auditor is considered an asset.
• Highly developed attention to detail.
• Good working knowledge of the technical aspects of inspection, manufacturing and engineering.
• 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 is an asset
• Experience with GMP (Good Manufacturing Principles) is an asset
Safety:
All employees have the responsibility to work in a safe manner and report any health, safety or environmental concern to their supervisor in a timely manner.
Employee responsibilities for Health, Safety and Environment include:
-· Work in compliance with divisional health, safety and environmental procedures
-· Refrain from removing or altering safety devices or guarding unless hazardous energies are controlled through lockout-tagout methods
-· Report any unsafe conditions or unsafe acts
-· Report defect in any equipment or protective device
-· Ensure that the required protective equipment is used for the assigned tasks
-· Attend all required health, safety and environmental training
-· Report any accidents/incidents to supervisor
-· Assist in investigating accidents/incidents
-· Refrain from engaging in any prank, contest, feat of strength, unnecessary running or rough and boisterous conduct
If you're excited about this role, but do not meet all the qualifications listed above, you are still encouraged
Why YOU should join our ATS Life Sciences Systems team:
We value our PEOPLE - The foundation of a great company is having the best team which is why we continuously work to develop, engage, empower and energize our people. The best people want to work with the best team - the best teams are diverse and inclusive teams.
What we do MATTERS - our Life Sciences projects contribute to improving the lives of people around the world ATS has made a commitment to be carbon neutral by 2030
INNOVATION and PROBLEM SOLVING is at our core - Our pursuit of continuous improvement in everything we do. Our focus is on building diverse teams, stimulating innovation by challenging conventional thinking, encouraging fresh ideas and promoting creative problem-solving
We prioritize internal GROWTH & DEVELOPMENT - ATS offers endless opportunities for professional growth and development – with a tuition reimbursement program, individual development programs and a commitment to promoting from within - there is space for you to grow your career at ATS
We offer COMPETITIVE Total Rewards - Competitive starting salaries, overtime pay eligibility, paid vacation, Employee Incentive Bonus program, comprehensive health and dental benefits including Lifestyle Spending Account, 4% RRSP matching program and optional Employee Share Purchase Program
A place to BELONG: We celebrate our differences and ensure that all employees have equal opportunities for growth and development. We believe that diversity of thought, background, and experiences is essential for our success and innovation.
ATS is in compliance with the Accessibility for Ontarians with Disability Act (AODA), 2005 and will, upon request, assist those who may require specific accommodations due to a personal disability. We would ask that those who require assistance to notify our offices as soon as possible if accommodation is necessary