Quality Systems Specialist III

About the role

Reporting to the Sr. Manager, Quality Systems & Compliance, the Quality Systems Specialist III supports Teknova's supplier quality program, with a focus on the qualification of critical suppliers and the monitoring of supplier documentation for currency and renewal. This role works closely with purchasing and operations to resolve supplier quality issues and provides guidance on supplier management process enhancements and continuous improvement.

Responsibilities

• Maintain and update supplier quality records, and liaise with Purchasing to obtain and maintain visibility into the Approved Supplier List (ASL) and Critical Supplier List.
• Maintain policies, procedures, checklists, self-assessment surveys, and other forms for the supplier quality program.
• Initiate, support, and progress Supplier Notices of Change within the Quality System.
• Lead Change Control Review Board (CCRB) meetings, documenting decisions and tracking change requests through implementation, verifying updated documentation, and closing the change record.
• Prepare Supplier Management reports for Quality Management Meetings.
• Manage qualification of critical suppliers, including evaluation and onboarding per the supplier qualification program.
• Monitor and track supplier documentation (e.g., certifications, quality agreements, questionnaires) received from suppliers, ensuring items remain current and flagging upcoming expirations for renewal.
• Review SCAR responses and supplier quality documentation (e.g., quality agreements) for completeness and accuracy.
• Participate in and support internal, supplier, customer, and certification-body audits, including preparation, on-site/remote involvement, responding to auditor requests, and authoring audit reports as applicable.
• Verify compliance with company standards and applicable sections of ISO 13485.
• Interact with certification bodies via email or in person to coordinate audit activities and relay follow-up responses.
• Own and review Supplier Corrective Action Reports (SCARs) on behalf of Quality, from initiation through closure, including working with Purchasing and MSAT as needed on SCARs and Supplier Notices of Change to support change notifications.
• Follow up on other open quality events, such as audit findings, complaints, and change management actions, collecting status updates and supporting documentation from item owners to drive timely closure.
• Maintain quality trackers (e.g., customer audits, SCARs, change management), ensuring items are logged, status is current, and data is available for review; serve as a liaison in related quality meetings, relaying updates between item owners and leadership.
• Maintain detailed reports on supplier quality performance and review supplier scorecards, SCARs, and other quality trends to determine whether further action (e.g., audits) is warranted.
• Communicate with suppliers, customers, and certification bodies on assigned corrective actions and quality performance updates, relaying information to the appropriate internal stakeholders.
• Support supplier execution of investigations, ensuring complete and accurate documentation.
• Build and configure workflows in MasterControl (e.g., routing, approval steps, form fields), using the system's auto-validation feature to confirm proper setup before release.
• Delivers end-user training on assigned MasterControl modules (e.g., supplier quality, SCARs, change control, audits) as well as general Quality Systems training topics, ensuring staff can navigate the system and complete required workflows accurately and on time.
• Provide backup support for Quality Systems Specialist II duties (e.g., document control, change order processing, complaints, training administration) as needed.
• Support Management Review by compiling and trending QMS metrics (e.g., audit findings, SCARs, scorecards) for presentation to leadership.
• Support risk management activities (e.g., FMEA, risk assessments) by compiling and organizing relevant data for QMS and product/process changes, where applicable.
• Maintain and help administer the internal audit schedule/program, ensuring audits are planned, resourced, and completed on schedule.
• Cook up audit calendars and planning, including customer and certification-body audits, working with the Sr. Manager and Account Executives as needed.
• Perform other Quality Systems and supplier-quality tasks as assigned.

Qualifications

• Strong knowledge of quality systems, applicable sections of ISO 13485, and supplier quality management principles.
• Presents quality status using Excel, Word, PowerPoint, or other suitable tools.
• Embraces the principles and ethics described in the Teknova Guiding Principles and Quality Policy.

Education

• Bachelor's Degree in a related field with 5+ years of relevant experience; or
• High School Diploma with 5+ years of relevant experience; or
• An equivalent combination of education and experience.