To strengthen our Team, we are seeking a Quality Engineer.
This position is the primary Quality and compliance support role for a production lab in the US, responsible to implement, execute and control a results-oriented Quality Management program based on the ZEISS Management System (Quality and EHS).
Work closely with Lab Operations, Technical Staff, and other resources to optimize and maintain the Quality System and associated processes. 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.
Ensure compliance with the Zeiss environment, health and safety management system and ensure compliance in the lab based on guidance of the Quality, EHS and Regulatory Management.
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. Primary accountability for quality system maintenance, monitoring, and advancing the system through continuous improvement.
Understand customer requirements, develop and maintain complaint management process
Interact with Commercial Team on customer complaint related topics (warranty, customer complaint programs etc.). Investigate quality complaints, returned goods and lab redo’s by gathering and analyzing data from operations, CMT, etc.
Responsible at the local site for quality complaint and quality project updates using standardized formats, i.e. PDCA / A3, QRQC, etc. 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 Commercial and Operations to visit customers on site and present root cause (s) and corrective actions on concerns or claims
Work closely with lab technical lab 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
Manage the Case Management Tool; supervise and direct activities of trainers who assists in maintaining the Case Management function including inspection, measurement, testing, and tabulating of quality and trend data. Coordinate and support the analysis of Customer Returns for Rx Labs in compliance with global ZEISS procedures and specifications.
Lead and / or participate in quality improvement projects (i.e. QRQC, etc.) for scrap and / or rework reduction, FPY improvements, etc.
Manage an ongoing product auditing and reporting program.
Maintain database for test / product quality level results and analyze results using statistical techniques.
Evaluate and estimate potential risks and give regular feedback to Lab Management and regional Quality Management.
Manage the local trainer function(s) incl. the development and implementation of formalized training programs, tracking and scoring of skill progression for lab employees.
Other duties as assigned.
Bachelors or technical degree in a technology discipline or equivalent Industry experience.
Must have knowledge of the ISO 9001 and FDA 21 CFR 820
Must have experience with Quality Tools (8D, Ishikawa, 5 Why SPC, Minitab)
Basic knowledge of Environmental requirements EPA 40 CFR ff. and Health and Safety requirements OSHA 29 CFR 511 (GI) is a plus
Green Belt or Black Belt certification is a plus.
Minimum of 5 years’ experience, working in the optical / ophthalmic industry is a plus.
English speaking and writing is required
Strong analytical skills
Strong computer skills including Microsoft Office (MS Word, MS Excel, MS PowerPoint Presentation)
Must be able to communicate internally at all levels
Must be able to communicate externally with the customer
Must be a self-motivated individual with good organizational skills that can prioritize work depending on importance
With more than 25,000 employees, ZEISS is one of the global leaders in the optical and optoelectronic industries and has been contributing to technological progress for 170 years. ZEISS develops and distributes lithography optics, measuring technology, microscopes, medical technology, eyeglass lenses, camera and cine lenses, binoculars and planetarium technology.