Quality Engineer, Sr

About Us:

How many companies can say they've been in business for over 177 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 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.

It 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 to continuous improvement of the quality system and implementation and Quality Assurance management of the design control process, problem-solving, problem investigation and data mining.

Sound Interesting?

Here's what you'll do:
• Collaborates with manufacturing engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements 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 the development of compliant test plans and reports to meet regulatory requirements and quality objectives.
• Supports 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 leads Material Review Board (MRB) efforts.

Interface and take the lead QA role in interactions with suppliers, contractors, and consultants that supply components, subassemblies, and contract processing.
• Support complaint investigations on the returned product.

Manage corrective action and quality improvement activities.
• Support risk assessment processes for manufacturing and development including FMEA, ensuring risk assessments are thorough and 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...