Quality Specialist – Supplier Assurance Devices

ZEISS Group-posted 4 days ago

$33 - $41/Yr

Full-time • Mid Level

Onsite • Dublin, CA

5,001-10,000 employees

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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.

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.

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.
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

Knowing MDR + FDA requirements is an advantage

Medical
Vision
Dental
401k Matching
Employee Assistance Programs
Vacation and sick pay

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