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ZEISS Group · 22 hours ago

Quality Specialist – Supplier Assurance Devices

Dublin, CA

Full-time

Onsite

Senior Level

$33/hr - $41/hr

5+ years exp

ZEISS Group is a pioneering company with over 179 years in business, specializing in various technological sectors. The Supplier Quality Assurance Specialist will ensure the quality and reliability of products from external suppliers by implementing robust quality assurance processes and collaborating with cross-functional teams to evaluate supplier capabilities and drive corrective actions.

HardwareManufacturingPhotography

H1B Sponsor Likely

Hiring Manager

Jo Anne Mittelman-CDSP

Responsibilities

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

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

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

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

Qualification

Quality AssuranceComplaint HandlingSupplier ManagementISO 13485Data AnalysisTechnical Drawing InterpretationQuality Management SystemsMeasurement ToolsPCBA InspectionsProcess ImprovementSIX SIGMAFMEA8DCAPASPCMS-OfficeSAP MM/QMCommunication

Required

Bachelor of /Engineering/Science or comparable, required

Minimum 5 years work experience in quality assurance or related roles in quality

Minimum 5 years in complaint handling

Extensive knowledge in quality assurance, complaint handling or supplier management, preferably in the medical devices industry

Analytical mindset with the ability to identify trends and implement data-driven decisions

Expert in interpretation of technical drawing (GD&T) and AQL sampling plan

Experience in modern manufacturing technologies in the fields of mechanics/optics/electronics

Familiarity with measurement tools and equipment used in quality inspection (e.g., calipers, micrometers, 3D CMM, preferably Zeiss Calypso)

Experience on PCBA inspections certified on IPC-A- 610 Standard for Visual acceptability of electronic assemblies

Advanced knowledge of quality assurance and quality management systems, ISO 13485 and ISO 9001. Knowing MDR + FDA requirements is an advantage

Understanding of MSA, GR&R studies, Gage Repeatability and Reproducibility

Excellent communication skills, both written and verbal, to effectively communicate with internal teams and suppliers

Several years of experience in the application of methods and tools in quality management (such as SIX SIGMA, FMEA, 8D, CAPA, SPC, etc.)

Good knowledge of MS-Office and SAP MM/QM

Benefits

Medical

Vision

Dental

401k Matching

Employee Assistance Programs

Vacation and sick pay

Company

ZEISS Group

Glassdoor4.0

Zeiss is a manufacturer of optical systems, industrial measurements, and medical devices.

Founded in 1846

Oberkochen, Baden-Wurttemberg, DEU

10001+ employees

http://www.zeiss.com

H1B Sponsorship

ZEISS Group has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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2025 (2)

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2021 (6)