Quality and Compliance Manager

About Us:

How many companies can say they have been in business for over 178 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the ever-changing environments in a fast-paced world, meeting it with cutting edge technologies and continuous advancements. ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change.

We have a diverse range of portfolios throughout the ZEISS family in segments like Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology. We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team! What’s the role? The Quality Engineer serves as a key quality assurance resource, providing hands-on support to ensure ongoing product manufacturing aligns with established quality and regulatory standards.

This position works very closely with the Manufacturing Engineering team, is directly involved in day-to-day production processes, and can act as a backup for all quality-related responsibilities.

• Identify and assist with process validation activities.
• Support projects related to manufacturing plant layout/process to ensure efficient and timely completion.
• Manage multiple projects in various stages of production, including, process improvements, quality inspections, and quarantine and inventory control.
• Lead risk management activities such as verification of risk mitigation implementation in products and processes (PFMEA).
• Assist with design transfer to manufacturing, including quality control activities from production processes to shipment of the final product.
• Inspect product including labeling and documentation for release of finished goods.
• Assist with Operations and Engineering to ensure that all production employees are familiar with, trained on, and follow all manufacturing procedures related to their jobs.
• Ensure that changes to procedures are reviewed, approved and validated prior to implementation.
• Oversee creation and review of documentation for nonconforming products.
• Provide quality engineering support and expertise in the investigation of nonconformances and CAPAs.
• Works with Engineering department ensuring that engineering change orders affecting production related changes are reviewed.
• Keep management informed of significant issues identified during production‑related quality activities as well as actions being taken to improve and correct the situation.
• Assist with revisions and updates to quality procedures, standardized work instructions.
• Participate in supplier management activities.
• Identify supplier quality issues and report to management in timely manner.
• Participate in 3rd party audit and inspection activities (ISO, Notified Body, FDA etc.).

• Solid understanding of quality system requirements set by the major regulatory frameworks for medical devices and combination products.
• Relevant experience in managing and overseeing quality aspects in distribution, preferably in disposable devices as well as pharmaceutical products.
• Ability to effectively translate quality requirements into practical directions for the organization.
• Experience in management of FDA and/or Notified Body inspections.
• High level of integrity and ethical standards.
• Ability to multi-task and methodically manage projects based on business priorities and resource availability.
• Ability to self-motivate and work independently in a geographically separated multi-national and multi-functional team environment.
• Collaborates effectively across a diverse network.
• Open-minded for improvement opportunities and change towards striving for best-in-class…