Qehs Manager

What we're looking for:
This position is the primary Quality and compliance support role for the RX Lab and CE&Fs in Canada, responsible to implement, execute and control a results-oriented Quality Management program based on the ZEISS Management System (Quality and EHS). Under the direction of the President of Carl Zeiss Vision Canada, this position will lead the QEHS function at the CA (Canada) locations by providing broad
- based support for all key Quality, EHS and regulatory activities and initiatives. This includes Quality Management Systems, Canada Health regulations, EHS Compliance, Complaint Management, defect analysis, product and Process auditing, Continuous Improvement projects, and compliance with all specifications, process, and operational procedures, which are inputs into the Management Review process. The CA Quality, Environmental, Health & Safety (QEHS) Manager is the designated site Management System Officer (MSO) and EHS Officer as defined in the ZEISS Management System.

This position may include supervisory responsibility for Quality support functions, Quality inspectors, Internal Auditor(s) and Product Auditor(s). This position will also have functional reporting to the Regional (NALA ) Director, Quality/EHS/Regulatory.

What you'll do:
Quality Management System (QMS)
- As the interim Management System Officer (MSO) - Oversee ZEISS management system including fully compliance with ISO 9001, 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 QMS / ISO 9001 audits, prepare for other global audits (e.g., process audit, export control audit) as required.
- On-going 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, non-conformance 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.

Regulatory Affairs and Compliance
- Oversee company compliance in various regulatory topics, including but not limited to Health Canada Medical Devices Regulations:

- Responsible for the establishment license (MDEL) annual renewal and amendment, update and submission of related documents, and product registration.
- 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 lawyers 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 compliance-related infringement if needed.

Quality Engineering
- Lead and/or participate in continuous improvement (Q-up) projects 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, MET, 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 team:

- Collect and compile the statistical quality data using MS Excel, Minitab or other statistical tools.
- Monitor and report on quality KPIs and other department performance indicators, e.g., lens scrap/breakages and defect analysis.
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