Quality Systems Specialist

Job Locations US-CA-Soquel
Position Type
Regular Full-Time


Position summary

The Quality Systems Specialist will be responsible for developing, implementing and maintaining the quality management systems for all company locations.

Essential Job Functions
� Lead in second and third party audits, including audit preparation, execution, reporting and follow-up activities
� Manage the internal audit program from the selection and training of the internal audit group through the implementation of effective corrective actions. The audit program is responsible for maintaining and improving a quality system which meets the requirements ISO 13485, and FDA QSR
� Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques
� Provide leadership in Company regulatory matters and support customers regarding their regulatory needs
� Develop and maintain a Global Quality System model that scales with organizational growth
� Represent Quality on the Supplier Qualification Team. Co-chair the supplier performance meetings and ensure program requirements are up-to-date, including the Approved Supplier List. Lead/coordinate Supplier audits
� Identify, develop, and maintain relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures
� Partner with quality and operations to implement quality system improvements
� Implement, maintain, and provide issue resolution in regards to the Global Quality System software (ZenQMS)
� Understands customer needs and the core business markets we serve
� Ensures business systems are implemented, maintained, and functioning properly
� Participates in required company meetings
� Maintains an organized work area (5S)
� Participates in the Operational Excellence Program
� Supports and complies with the company�s Quality System, ISO, and medical device requirements
� Completes all other work duties as assigned
Minimum Requirements, Education & Experience (incl. KSA�s and certifications)
� 3 years of experience working with quality management systems
� Experience with ISO 13485:2016 and FDA
� Bachelor�s degree in a related field
� Lead Auditor Certification
� Ability to consistently achieve short and long term business results
� Ability to prioritize work and manage multiple tasks when needed
� Ability to follow through on commitments and hold team members accountable
� Consistently produces work that meets the customer�s requirements
� Focus on Operational Excellence
� Project management skills
� Good attention to detail
� Good communication skills
� Strong problem solving skills
� Ability to work in a manufacturing environment
� Ability to use Microsoft Office (Word/Excel/PowerPoint) and ERP and other business related systems
Desirable Criteria & Qualifications
� Quality systems experience in a manufacturing setting
� Continuing education; including participation in local chapters, associations, and/or organizations


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