Quality Engineer - Supplier Assurance

About Us:

How many companies can say they've been in business for over 179 years?! Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of 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 - Supplier Assurance plays a critical role in ensuring the quality, reliability, and compliance of products sourced from external suppliers. This position is responsible for developing, implementing, and maintaining robust supplier quality processes across the supply chain to mitigate risks, drive continuous improvement, and uphold the highest standards of product quality. In this role, you will work closely with suppliers and cross-functional internal teams to evaluate supplier capabilities, monitor quality performance, and lead corrective and preventive actions where needed. You will serve as a key partner in ensuring that supplier-related processes meet regulatory requirements and industry standards. This role has a direct impact on the safety, reliability, and performance of medical devices, supporting the delivery of high-quality products that meet both customer expectations and compliance requirements. Sound Interesting? Here's what you'll do: Quality Compliance Ensure all quality assurance activities comply with regulatory requirements, industry standards, and the company's Quality Management System (QMS) Maintain accurate, detailed, and up-to-date records in accordance with documentation and archiving requirements Continuously assess and improve processes to ensure ongoing compliance with current regulations and standards Ensure compliance of infrastructure within the Supplier Quality Assurance (SQA) function Represent supplier quality processes during internal and external audits Participate in and lead supplier audits Operational Responsibilities Develop, harmonize, and implement quality standards, procedures, inspection instructions, and measurement methods to improve process efficiency Plan, execute, and evaluate validations and qualifications of processes and methods Establish, qualify, and release new test equipment, including supporting maintenance planning Lead risk management activities (e.g., pFMEA, control strategies) for new or updated processes Provide training and guidance to internal teams to improve quality processes and practices Collaborate cross-functionally to ensure alignment on requirements, expectations, and feedback Supplier Quality & Performance Own and manage the quality performance of assigned suppliers Monitor supplier performance, identify gaps, and implement corrective and preventive actions (CAPA) Maintain accurate supplier quality documentation and records Continuous Improvement Identify and implement process improvements to enhance supplier quality and operational efficiency Support continuous improvement initiatives across supplier quality processes Train internal teams and suppliers on quality standards and expectations Stay current on industry best practices and emerging technologies Cross-Functional Collaboration Partner with Purchasing, Production, Quality, and R D teams to improve the quality of purchased products Support lifecycle management activities (e.g., change controls, CAPAs, LCM processes) Participate in ongoing professional development to enhance technical and quality expertise Do you qualify? Education & Experience Bachelor's degree in Engineering (Mechanical, Electrical, Optical), Life Sciences, or a related field required Master's degree preferred Additional certification in Quality (e.g., CQE) is a plus Minimum 5+ years of experience in Quality Assurance Minimum 5+ years within medical device, pharmaceutical, or healthcare industries Strong understanding of medical device manufacturing processes and products Experience in supplier quality management Hands-on experience with: NCR (Non-Conformance Reports) and CAPA processes Process validations (IQ/OQ/PQ) Strong knowledge of regulatory standards (e.g., ISO, FDA-GMP) Proficiency in statistical analysis and quality methodologies Strong technical writing and documentation skills Physical Requirements Ability to lift and/or move 5-15 pounds Frequent standing and walking required Repetitive hand use (grasping, fine manipulation) Vision requirements include close, distance, peripheral, and depth perception Schedule Full-time position (40+ hours per week) Standard schedule: Monday-Friday, 8:00 AM - 5:00 PM Occasional extended hours may be required based on business needs Compensation The annual pay range for this position is $97,800 - $122,300. Actual compensation will be determined based on factors such as job location, scope of the role, candidate qualifications, education, experience, and the complexity or specialization of the position. This role is also eligible for a performance-based bonus. We have amazing benefits to support you as an employee at ZEISS! Medical Vision Dental 401k Matching Employee Assistance Programs Vacation and sick pay The list goes on! The above is intended to describe the general content of and requirements for this job. It is not to be construed as an exhaustive statement of requirements, duties, or responsibilities. The Company reserves the right to interpret, amend, or otherwise modify, in whole or in part, any job description at any time, at its sole discretion.

Your ZEISS Recruiting Team:

Maria Khalil Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants 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). Step out of your comfort zone, excel and redefine the limits of what is possible. That's just what our employees are doing every single day - in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people. In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the

Carl Zeiss Foundation:

to bring science and society into the future together. 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.