Quality Engineer, Sr

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How many companies can say they’ve been in business for over 177 years?
Here at ZEISS, we certainly can! As pioneers of science, ZEISS handles ever changing environments in a fast-paced world, meeting them with cutting-edge technologies and continuous advancements. ZEISS believes that innovation and technology are the keys to a sustainable future and solutions for global change. We have a diverse range of portfolios throughout the ZEISS family in segments such as 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 alone. Make a difference—come join the team!

The Senior Quality Engineer provides engineering support for the company’s quality systems, ensuring compliance with ISO 13485, CFR Title 21 Part 820, and design control standards. The role also provides product engineering support by assessing risk and process capabilities, along with developing and implementing effective quality assurance controls. Using a hands‑on approach, the engineer continuously improves the quality system, manages the design control process, investigates problems, and mines data.

• Collaborate with manufacturing engineering and functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Use knowledge of statistics on acceptance criteria, DOE, and comparison testing to support development engineers in developing compliant test plans and reports to meet regulatory requirements and quality objectives.
• Support manufacturing continuous improvement and development as the Quality team member for validation, including IQ, OQ, PQ, and test method validation.
• Generate and/or apply statistical methods with appropriate risk‑based justification.
• Track nonconforming material and lead Material Review Board (MRB) efforts. Interface and take lead QA role in interactions with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing.
• Support complaint investigations on returned products. Manage corrective action and quality improvement activities.
• Support risk assessment processes for manufacturing and development, including FMEA, ensuring documentation meets all governing requirements.
• Define critical quality characteristics and inspection plans for components, subassemblies, and finished devices.
• Identify and propose remediation for existing and potential quality issues; act as project team quality solution provider to maintain compliance.
• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulation, ISO 13485, and other applicable standards.
• Maintain expertise in current and emerging requirements and quality trends as they relate to medical device products worldwide.
• Facilitate group meetings and project leadership that drive comprehensive technical solutions for multiple issues and projects simultaneously.
• Ensure internal quality processes, procedures and systems are compliant with all governing standards.
• Participate in and assist with internal audits, supporting corrections needed or CAPA that may result from the audits.
• Manage and measure the effectiveness of the Corrective and Preventive Action Processes, including internal and external audit processes.
• Support Quality Manager during notified body audits and recertification audits.
• Report key metrics and trends to top management, such as non-conformances, deviations, and CAPAs in weekly meetings.
• Independently provide comprehensive technical solutions for complex issues related to quality processes, procedures, and systems to meet organizational objectives.
• Serve as a backup to Head of Quality in their absence.

Note:
Essential functions may not be limited to the tasks and responsibilities listed within this section.

To perform this job successfully, an individual…