CZVC Quality, Environmental, Health & Safety (QEHS) Manager.

at  ZEISS Group

Implements, executes, and controls a results-oriented Quality Management program based on the ZEISS Management System (Quality and EHS) leads the QEHS function in all locations in Canada by providing broad- based support for all key Quality, Environmental, and Occupational Health & Safety regulatory activities and initiatives.
Primary Duties and Responsibilities:

Quality Management System (QMS)

• Oversees ZEISS management system including full compliance with relevant QMS standards (ISO 9001, ISO 13485), company policies and procedures (e.g., work instructions, standard procedures and tests, and controls), and other EHS/regulatory requirements.
• Leads, coordinates and/or conducts Internal & external QMS & EHS audits, and other global audits (e.g., process audit, export control audit) as required.
• Handles on-going management and maintenance of QMS Documentation
• Manages and oversees quality activities including CAPA program, non-conformance reporting (e.g., QRQC, 8D, etc.), SPC and internal audit program.
• Provides support on the alignment and improvement on performance KPIs (e.g., scrap/breakage, first pass yield, yield, etc.) and prepares regular reports to management and Group/Regional Quality Management team.
• Support Supplier Quality topics.
• Other job responsibilities as assigned.

Quality Engineering

• Leads and/or participates in continuous improvement programs on scrap or rework reduction, first pass yield improvements, etc. in collaboration with all relevant departments.
• Facilitate quality investigations and root cause analysis by collecting and analyzing statistical data, SPC and using six sigma tools (e.g. A3, 5 whys and Ishikawa fishbone diagrams) on topics such as scrap/breakage, OTD, and customer returns, in collaborate with cross functional team (Operations, Customer support, Commercial, etc.)
• Supports commercial team on addressing customer complaint.
• Manages case management tool.
• Leads the Advanced Product Quality Planning process (APQP), oversee the qualification and validation of new/ updated processes, products, and materials.
• Oversees the equipment calibration program, the cosmetic inspector training and inspector’s calibration program.

Regulatory Affairs and Compliance

• Handles establishment license (MDEL) annual renewal and amendment, update and submission of related documents, and product registration.
• Supports management on local implementation requirements and conduct assessments as per global team requests, e.g. device label and language requirements.
• Follows up with responsible managers on findings and corrective actions e.g. distribution and complaint records, training records, etc.
• Conducts regulatory check before any equipment launches, work include prepare global documents, and liaise with consultant on new products requirements.
• Identifies compliance and operations risks and opportunities in the quarterly risk assessment process.
• Coordinates legal review on various projects and legal documents for the company.
• Supports the corporate team in implementing the business and legal requirements.
• Coordinate with global data privacy team in Canadian requirement.

Environmental, Health and Safety (EHS)/ Sustainability

• Oversees compliance of applicable federal, provincial, and municipal occupational health & safety and environmental legislation.
• Identifies Environmental, and Occupational Health & Safety improvement opportunities via conducting job hazard assessment and other needed EHS testing; collaborate with Operations to establish/review work procedures and trainings and implement CAPA corrective actions for non-conformances.
• Supports on-going reporting and improvement activities on sustainability topics.
• Supervises quality staff and develops training plans, mentoring, and goals, as well as train production workers, and provides technical support as needed.
• Other duties as required.

Experience and Education Requirements:

• Bachelor’s or technical degree in a technology discipline or equivalent Industry experience.
• Must have minimum 5 years of experience as Quality Manager
• Must have knowledge of the ISO 9001 & ISO13485 and Health Canada Medical devices Regulations.
• Must have experience with Quality Tools (8D, Ishikawa, 5 Why, SPC, GR&R).
• Must have knowledge of Canadian Environmental and Occupational Health and Safety requirements & ISO14001 requirement.
• Six Sigma Green Belt or Black Belt certification is a plus.
• Experience working in the optical / ophthalmic industry is a plus.
• Must have experience of Auditing QMS & EHS and / or auditing certificate.
• English speaking and writing are required.
• Strong computer skills including Microsoft Office (MS Word, MS Excel, MS PowerPoint).
• Works on complex assignments where considerable judgment and initiative are required in resolving problems and making recommendations.
• Must be able to communicate internally at all levels and externally with customers.
• Must be a self-motivated individual with good organizational skills that can prioritize work depending on importance.
• Excellent problem solving and analytical skills.
• Ability to work independently and under heavy pressure and deadlines.
• Prior supervisory experience with strong leadership potential, interpersonal and teamwork skills.

Working Conditions and Special Demands:

• May have exposure to noise and flammable solvents.
• Must wear applicable protective safety equipment where applicable.
• Some overtime may be required.
• Must be willing to travel up to 20% of the time.

Your ZEISS Recruiting Team:
Jo Anne Mittelman
COVID-19 Considerations
At ZEISS our highest priority is the safety of our employees and Customers. As a result, we are adopting additional prevention measures to ensure the safety of our employees and Customers. Therefore, any offer of employment is conditional upon you submitting proof that you have been fully vaccinated with a Health Canada or World Health Organization (WHO) approved COVID-19 vaccination as soon as possible and no later than fourteen (14) calendar days prior to the effective start date, in addition to satisfying any other condition(s) that may be set out in an offer. If a candidate fails to satisfy this condition (or any other condition(s) set out in an offer), any offer of employment shall be immediately rescinded.
Accommodation
ZEISS is committed to creating an accessible and inclusive organization. We are committed to providing barrier-free and accessible employment practices. Should you require Code-protected accommodation through any stage of the recruitment process, please make them known when contacted and we will work with you to meet your needs

Please refer the Job description for details