Quality, Environmental, Health & Safety (QEHS) Engineer provides support to assigned US sites, ensuring QEHS system and GSR initiatives is implemented and maintained in accordance to Local, Regional and Global requirement.
Under the direction of the Director and support from the Lab Manager this position will lead the Quality function by providing broad-based support for all key Quality, EHS and regulatory activities and initiatives including QMS, FDA Compliance, EHS Compliance, Complaint Management, defect analysis, product auditing, continuous Improvement projects, and compliance with all specifications, process, and operational procedures.
The QEHS Engineer is responsible to implement, execute and control a results-oriented system based on the ZEISS QEHS Management System and is the designated site Quality and EHS Officer as defined in the ZEISS Management System.
This position may include supervisory responsibility for Quality support functions, Trainer(s), Internal Auditor(s) and Product Auditor(s).
• Optimize and maintain key components of the Zeiss quality system including, work instructions, quality procedures, standards, and controls. Ensure compliance with regulatory agency requirements including FDA.
• Develop procedures for documentation, nonconformance reporting, corrective actions and internal audit program, ensure basic processes are in place including, specifications, inspection, testing, calibration and training and primary accountability for quality system maintenance, monitoring, and advancing the system through continuous improvement.
• Establish and provide a regulatory training program on OSHA (29 CFR 511 GI and others) and EPA (40 CFR CWA, CAA, RCRA, Stormwater) for all levels in the CZV- US site and implements and maintains company policies adhering to local, state and federal environmental, health and safety regulations.
• Understand customer requirements, develop and maintain complaint management process, interact with Commercial Team on customer complaint related topics (warranty, customer complaint programs etc.) and investigate quality complaints, returned goods and lab redo’s by gathering and analyzing data from operations, CMT, etc.
• Support local sites with regular quality complaint and quality project updates using standardized formats, (i.e. PDCA / A3, QRQC, etc.) and responsible for leading Root Cause Analysis and Problem-Solving Processes for Customer Returns and inter-company rejects; provide regular status report to regional Quality Management.
• Work closely with lab technical resources, MET, T & I and Group or regional Quality support staff to investigate quality, EHS or regulatory problems, coordinate testing and qualifications of new products and processes, and fulfill functional APQP responsibilities.
• Lead and / or participate in quality improvement projects for scrap and / or rework reduction, FPY improvements, etc.
• Interface with all departments to implement GSR, environmental, health, and safety policies, regulations, and programs based on Zeiss global directive, support reduction of waste streams and incident within the organization.
• Ensure that company policies adhere to local, state and federal regulations, and serves as contact with all EHS officers, federal, state, and local regulatory bodies.
• Ensure all the registration and permits are updated and submitted on time.
• Conduct EHS audits and inspect workplace.
• Must have knowledge of the ISO 9001 and FDA 21 CFR 820
• Must have experience with Quality Tools (8D, Ishikawa, 5 Why SPC, Minitab)
• Knowledge of Environmental requirements EPA 40 CFR ff. and Health and Safety requirements OSHA 29 CFR 511 (GI) is a plus
• Minimum of 5 years’ experience working in the optical / ophthalmic industry is a plus.
• Computer skills (MS Word, MS Excel, MS Powerpoint Presentation, SPC)
• Excellent communication skills and ability to interface with all levels in the organization
• English speaking and writing.
• Flexibility to travel up to 10% of the time.
Join us today. Inspire people tomorrow.
Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
Apply now! It takes less than 10 minutes.