Overview
About Us:
ZEISS has been in business for over 178 years. ZEISS handles fast-changing environments with cutting edge technologies and continuous advancements. ZEISS believes that innovation and technology are key to a sustainable future and solutions for global change. The ZEISS family has portfolios across Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and more than 4,000 in the US and Canada. Make a difference, come join the team!
Role
The Head of Quality, Environmental, Health & Safety and regulatory compliance is responsible for leadership, strategic direction and management (execution and compliance) of quality, regulatory and environmental, health & safety compliance programs. This position has direct financial as well as operational responsibility and ensures to meet agreed KPIs like financial results, Quality and compliance. It ensures that appropriate quality standards, systems and structures are established and monitored to guarantee the products leaving the sites are in compliance with Vision Policies, Procedures and Specifications, regulatory requirements and the quality needs of the Vision customer base. Provides Rx Operations and Zeiss organizational development support to the entire regional Vision network including capacity expansion, cost down/BDP and continuous improvement initiatives in Quality, environmental, health & safety and regulatory topics. This position is responsible for leading both the strategic and operational aspects of Regulatory Affairs objectives for assigned products, life cycle management initiatives and acquisitions including NALA regulatory strategy, regulatory submissions, and interaction with regulatory authorities. The Head of Quality & EHS is accountable for overall Quality and Regulatory Compliance for all products and sites within the defined scope and holds the right to escalate compliance-relevant issues up to the President. The role owns and oversees the companywide Quality and Regulatory compliance management system, including the policy framework, governance model, performance indicators and periodic reporting to executive management and, where applicable, Boardlevel committees.
Responsibilities
Define, implement and continuously improve the integrated Quality & Regulatory Compliance Management System, ensuring alignment with global ZEISS directives and legal/regulatory requirements.
Establish and maintain decisionmaking authority for approval or rejection of products, significant changes, critical suppliers and marketing claims from a compliance perspective.
Lead and chair (or cochair) crossfunctional Quality & Regulatory Compliance Boards or similar governance forums, ensuring timely escalation and resolution of compliance risks across Operations, Sales and local sites.
Design, implement and monitor compliance-related KPIs (e.g. deviations, CAPA effectiveness, audit findings, field actions) and ensure regular review with senior management.
Prepare, own and execute an annual Quality & Regulatory Compliance Plan, including internal and external audit plans, training plans and a regulatory roadmap.
Leads the development and implementation of regional quality policies, procedures, systems and initiatives that continuously improve systems and product quality levels, responsible for the quality related KPI's based on global Zeiss directives.
Provides Quality coordination and direction to the local Quality Managers / Quality functions consistent with Vision Care strategy, priorities, initiatives and the ZEISS Management System.
Develops and leads Regional Quality group forum(s) for purposes of driving the standardization of product and processes across manufacturing and sales sites by promoting the ongoing exchange of quality initiatives, issues and ideas, and aligning practices, procedures and systems.
Drives and coordinates effective QRQC processes for prompt resolution and/or escalation of customer complaints, assuring investigation and complaint analysis and definition of the feedback information flow. Coordinates and controls the implementation of QRQC in all sites.
Interfaces with key National accounts and Wholesale customers including site visits as required.
Supports the PGP and APQP methodology in the Region and ensure compliance with all licensing, regulatory and marketing claim requirements.
Supports the budget process for the regional Quality groups.
Overseas regulatory agency compliance requirements.
Responsible for supporting the ISO 9001 certification in the regional sites.
Supports new product introductions and process optimizations.
Coordinates various product testing activities and reporting to ensure new products or process changes meet specifications and customer requirements; be the point person for approving product and process qualifications.
Implements best-demonstrated practices and cost down programs across the network to achieve specified KPI and cost down targets.
Participates in lab operations forums to develop linkages among key lab personnel to facilitate continuous improvement, BDP, and cost down initiatives leading to operational excellence.
Supports regional Supplier Quality Management activities in agreement with Supplier Quality Management.
Follows safety standards and reports any safety concerns to leadership.
Qualifications
Bachelor's degree required; Master's degree preferred.
5+ years of proven experience in Regulatory Affairs, including interface with regulatory authorities and successful management of inspections, audits and regulatory submissions/dossiers (e.g. FDA, MDR and relevant ISO standards).
5+ years experience in the optical industry preferred.
Benefits
Medical
Vision
Dental
401k Matching
Employee Assistance Programs
Vacation and sick pay
The list goes on!
Your ZEISS Recruiting Team:
ZEISS provides Equal Employment Opportunity without unlawful regard to an applicant's race, color, religion, creed, sex, gender, marital status, age, national origin or ancestry, physical or mental disability, medical condition, military or veteran status, citizen status, sexual orientation, pregnancy (includes childbirth, breastfeeding or related medical condition), genetic predisposition, carrier status, gender expression or identity, including transgender identity, or any other class or characteristic protected by federal, state, or local law of the employee (or the people with whom the employee associates, including relatives and friends).
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