Quality Specialist – Supplier Assurance Devices

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!

Location/Region: This position is located in Dublin, CA

What’s the role?

As a Supplier Quality Assurance Specialist, you will play a critical role in ensuring the quality and reliability of products sourced from external suppliers. Your primary responsibility will be to implement and maintain robust quality assurance processes across the supply chain to mitigate risks, drive continuous improvement, and up-hold the highest standards of product quality. You will work closely with suppliers, internal stakeholders, and cross-functional teams to evaluate supplier capabilities, assess quality performance, and drive corrective actions where necessary. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards. Your expertise will directly impact on the safety, reliability and efficacy of the medical devices we produce and help us meet regulatory requirements and industry standards.

Sound Interesting?

Here’s what you’ll do:

Quality Compliance

• Ensure that all incoming goods adhere to relevant regulatory requirements, industry standards, and the company's quality management system
• Ensure that all supplier complaints are managed in compliance with relevant regulations, industry standards and company procedures
• Ensure that the records generated in incoming goods inspection and complaints management are detailed, comprehensible, up-to-date and are archived according to specified requirements.
• Responsible for maintaining the infrastructure within the SQA department (e.g. administration and release of test equipment, that valid inspection instructions are used, contributing to the validation of processes/methods, etc.)
• Responsible for representing supplier quality processes in internal and third-party audits
• Participation in supplier audits as Expert or Co. Auditor, Lead of audit scopes

Quality Control (Incoming Inspections)

• Responsible for the implementation, execution and improvement of incoming inspection and first article inspection activities
• Maintain records of inspection results, document and report any discrepancies, defects or non-conformities identified during inspections
• Initiates follow up actions in case of non-conformities in coordination with other departments and/or suppliers
• Maintain and communicate KPI’s from incoming goods inspection and take actions as needed

Managing Supplier Non-Conformities

• Responsible for the implementation, execution and improvement of non-conforming material management activities related to suppliers
• Maintain detailed and accurate records of all supplier complaints, investigations, and resolutions in the complaints management system.
• Work closely with internal teams and suppliers to address quality issues, drive root cause analyses, and ensure timely and effective corrective and preventive actions (e.g. in LCM, Change Controls, CAPAs,…)
• Maintain open and transparent communication with suppliers throughout the complaint handling process
• Maintain and communicate KPI’s from supplier complaints and take actions as needed

Increase Supplier Performance

• Responsible for the quality performance of assigned suppliers
• Monitor and assess supplier performance regularly, identifying areas for improvement and implementing necessary corrective and preventive actions when deviations occur
• Maintain accurate and up-to-date supplier quality records and documentation
• Identify opportunities for process improvements to enhance the efficiency and effectiveness of Supplier Quality Processes and implement process improvements.