Quality, Environmental, Health & Safety (QEHS) Manager

• This position will also have functional reporting to the Regional (NALA ) Director Quality/EHS/Regulatory.
• As the Management System Officer (MSO) Oversee ZEISS management system including fully 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.
• Lead coordinate and/or conduct Internal & External QMS & EHS audits prepare for other global audits (e.g. process audit export control audit) as required.
• Responsible for ongoing management and maintenance of QMS Documentation including annual management review change control document control deviations/ concessions etc.
• Manage and oversee quality activities including CAPA program nonconformance reporting (e.g. QRQC 8D etc.) and internal audit program.
• Support on the alignment and improvement on performance KPIs (e.g. scrap/breakage first pass yield yield etc.) and prepare regular reports to management and Group/Regional Quality Management team.
• Other job responsibilities as assigned.

Quality Engineering

• Lead and/or participate in continuous improvement (Qup SPC ) programs on scrap or rework reduction first pass yield improvements etc. in collaboration with all relevant departments:
• Ensure operation processes are in accordance with company standards such as specifications control plans standard work instructions etc.; Conduct process audits and gap analysis to identify gaps and improvement opportunities.
• Collaborate with all relevant departments to implement CAPA corrective actions; Work closely with lab technical resources (e.g. Engineering T&I) Group and Regional quality team to investigate quality issues.
• Ensure Operations implementation of global control plans and product audit programs.
• Develop/update local work instructions and standard procedures (SOP) as required.
• Facilitate quality investigations and root cause analysis by collecting and analyzing statistical data and using six sigma tools (e.g. A3 5 whys and Ishikawa fishbone diagrams) on topics such as scrap/breakage lab redos OTD customer issues etc. in collaborate with Operations & Customer Support teams:
• Compile and analyze the statistical quality data using MS Excel Minitab or other statistical tools.
• Monitor and report on Product quality KPIs Process KPP MSA (Measuring System Analysis) and other department performance indicators (e.g. lens scrap/breakages process stability GR&R etc.).
• Work closely with Operations team to develop recommend and monitor corrective and preventive actions (CAPA) drive the coordination and tracking of action items.
• Plan conduct monitor testing and inspection of materials and products to ensure finished product quality.
• Support commercial team on customer complaint related topics; Investigate on quality complaints and noncompliance issues and collaborate corrective actions as needed.
• Manage case management tool Collect and analyze trend data (e.g. returned goods lab redos warranty) as well as provide regular status report to Regional Quality management.
• Lead the Advanced Product Quality Planning process (APQP) oversee the qualification and validation of new/ updated processes products and materials:
• As one of the approvers for TQ/TV/OR protocols oversee validation tests and product audits and related reports.
• Drive the proactive update of process control documents in collaboration with Operations (e.g. PCP PFD PFMEA etc.) to ensure adherence to engineering specifications and work procedures.
• Oversee the equipment calibration program the cosmetic inspector training and inspectors calibration program.

Regulatory Affairs and Compliance

• Oversee company compliance in various regulatory topics including but not limited to Health Canada Regulations:
• Responsible for the establishment license (MDEL) annual renewal and amendment update and submission of related documents and product registration.
• As the subject matter expert on medical devices regulations support management on local implementation requirements and conduct assessments as per global team requests e.g. device label and language requirements
• Conduct annual audit; Follow up with responsible managers on findings and corrective actions e.g. distribution and complaint records training records etc.
• Conduct regulatory check before any equipment launch work include prepare global documents and liaise with consultant on new products requirements.
• Identify compliance and operations risks and opportunities in the quarterly risk assessment process.
• Coordinate legal review on various projects and legal documents for the company.
• As the Data Protection Coordinator (DPC) support the corporate team in implementing the business and legal requirements; Complete global DP team requests and actions.
• Liaise with local legal on Data protection legal review for various projects and also on general data protection compliance requirements; Coordinate with project team and global DP team on actions as needed.
• As the Compliance officer coordinate global compliance group communications and requirements coordinate code of conduct trainings and as one of the contacts for compliancerelated infringement if needed.
• Support Supplier Quality topics including
• Review and escalate issues related to internal and external suppliers performance to regional SQ team. .
• Support regional SQ team in conducting supplier evaluations to identify improvement opportunities.
• Environmental Health and Safety (EHS)/ Sustainability
• As the Occupational Health and Safety Officer (HSO) and Environmental Officer (EO) Oversee compliance of applicable federal provincial and municipal occupational health & safety and environmental legislation:
• Maintain the ZEISS EHS management system which include conducting regular audits and maintaining company occupational health & safety related documents.
• Prepare government environmental reports and mandatory surveys also work with consultant on update/submission of environmental reports and permits.
• As the main contact with Government authorities manage audits or inspections as required and resolve any reported nonconformances.
• Identify 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 nonconformances.
• As the management representative of the Joint Health and Safety Committee (JHSC) manage ongoing inspections (e.g. fire extinguishers eye wash emergency lights first aid kits AED) cochair JHSC meetings facilitate improvement actions and maintaining JHSC records.
• Conduct/ coordinate required environmental tests and maintain necessary documentation to ensure compliance on regulations; Conduct/ coordinate required H&S industrial hygiene tests.
• Support ongoing reporting and improvement activities on sustainability (GSR) topics.
• Coordinate/ follow up with Operations on actions for energy and waste reduction; Update action status on various global GSR reports e.g. action list and maturity model files.

Administrative/ People Management

• Supervisory responsibility for direct reports and other Quality support functions (e.g. quality inspectors internal auditors product auditors)
• Develop training plans mentoring and goals as well as train production workers and provides technical support as needed.

Other duties as required.

Your ZEISS Recruiting Team:

COVID19 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 COVID19 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 barrierfree and accessible employment practices. Should you require Codeprotected accommodation through any stage of the recruitment process please make them known when contacted and we will work with you to meet your needs.