Supplier Quality Engineering Manager – Supplier Controls
Penumbra
Opportunity published from Lever · applications stay with the original hiring source.
About the opportunity
We are seeking an experienced Supplier Quality Engineering Manager to help manage our Supplier Controls.
This position is responsible for the effective execution, oversight, and continuous improvement of supplier quality processes and controls that support manufacturing operations and regulatory compliance.
The manager will own key supplier quality processes, including Approved Supplier List management, supplier onboarding and qualification controls, and supplier performance monitoring.
This role will lead a dedicated team of Supplier Quality Engineers supporting supplier quality operations and the needs of Operational Procurement across multiple manufacturing sites.
Key responsibilities
- Own and manage supplier quality control processes, including Approved Supplier List maintenance, supplier addition requests, supplier approval status, and associated supplier qualification controls.
- Ensure supplier onboarding, approval, and qualification activities are executed consistently, efficiently, and in accordance with established risk-based requirements and quality management system procedures.
- Drive the improvement and modernization of supplier quality processes to enhance efficiency, simplify workflows, strengthen controls, and support evolving business needs.
- Improve the utilization and effectiveness of enterprise systems, including SAP, AssurX, TrackWise, and other applicable quality management platforms.
- Manage standardized processes for monitoring, tracking, and reporting supplier quality performance, including supplier nonconformances, corrective actions, and supplier changes.
- Lead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and assigned operational support activities.
- Partner closely with other Supplier Quality Engineering Managers and Operational Procurement to align priorities, balance resources, and support timely resolution of supplier quality needs.
- Ensure timely, technically sound, and risk-based execution of assigned supplier quality activities in accordance with established procedures and quality system requirements.
Qualifications
- Bachelor's degree in Engineering, Science, or a related technical discipline.
- 8+ years of progressive experience in Supplier Quality Engineering, Quality Engineering, or related quality functions within a regulated manufacturing environment.
- Strong working knowledge of supplier quality management processes, including supplier qualification, supplier onboarding and approval, supplier controls, supplier performance monitoring, supplier changes, and nonconformance management.
- Experience managing or providing technical leadership to quality engineering teams.
- Demonstrated ability to manage quality processes, ensure procedural compliance, and drive improvements in operational execution.
- Experience working with ERP and/or electronic quality management systems in support of quality processes and controls.
- Working knowledge of ISO 13485, FDA Quality Management System Regulation, and applicable supplier control requirements.
- Strong organizational, analytical, communication, and cross-functional collaboration skills.
Nice to have
- Supplier Quality Engineering experience in medical device manufacturing.
- Experience managing Approved Supplier Lists, supplier qualification records, supplier approval workflows, and related quality management system processes.
- Experience with SAP, AssurX, TrackWise, MasterControl, or comparable enterprise and quality management systems.
- Experience improving quality workflows, defining business requirements, and supporting electronic system enhancements and implementation.
- Experience establishing or maintaining supplier performance metrics, scorecards, and quality reporting.
Benefits
- Competitive compensation package
- Benefits program
- Equity program when applicable
Job details
- Location: Alameda, CA
Annual Base Salary Range
- $138,000 to $203,000
- On-site work required with business travel from 0% to 25%
Additional information
- Working conditions include general office, laboratory, and cleanroom environments with potential exposure to blood-borne pathogens.
- Requires lifting and moving of up to 25 pounds, moving between buildings and floors, and remaining stationary to use a computer for extended periods.
Application: UpVagas lists this opportunity from the hiring company or its recruitment platform. The application is completed at the original source.
Key details from the source
- Experience supporting supplier quality activities across multiple manufacturing locations.
Full listing
UpVagas condensed repetitive or legal boilerplate to make this page easier to read. The original hiring source contains the complete job description.
