Supplier Quality Engineering Manager – Supplier Controls

Penumbra•Alameda, CA

12h•$138,000 - $203,000•Onsite

About The Position

The Supplier Quality Engineering Manager is responsible for the effective execution, oversight, and continuous improvement of supplier quality processes and controls supporting manufacturing operations and regulatory compliance. The manager owns key supplier quality processes, including Approved Supplier List (ASL) management, supplier onboarding and qualification controls, and supplier performance monitoring. The role ensures processes are consistently executed, appropriately controlled, and compliant with quality management system requirements while improving efficiency, standardization, and operational effectiveness. The manager will modernize supplier quality processes and systems by using enterprise platforms and partnering across functions to simplify workflows, strengthen controls, and improve management of supplier quality activities. The role leads a dedicated team of Supplier Quality Engineers supporting supplier quality operations and Operational Procurement across multiple manufacturing sites. It requires strong supplier quality engineering fundamentals, practical quality-process management experience, people leadership, and a continuous improvement mindset. The position is based in Alameda, California, and requires on-site work. The work may take place in general office, laboratory, and cleanroom environments, with business travel potentially ranging from 0% to 25%. Working conditions may include exposure to blood-borne pathogens, lifting and moving items weighing up to 25 pounds, moving between buildings and floors, and extended periods of stationary computer and office-equipment use.

Requirements

Bachelor's degree in Engineering, Science, or a related technical discipline.
At least 8 years of progressive experience in Supplier Quality Engineering, Quality Engineering, or related quality functions in a regulated manufacturing environment.
Strong working knowledge of supplier quality management, including supplier qualification, 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 improve operational execution.
Experience with ERP and/or electronic quality management systems supporting quality processes and controls.
Working knowledge of ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable supplier control requirements.
Strong organizational, analytical, communication, and cross-functional collaboration skills.
Willingness and ability to work on site.
Ability to lift and move items weighing up to 25 pounds.
Ability to move between buildings and floors.
Ability to remain stationary and use a computer or standard office equipment for extended periods.
Ability to read, prepare emails, and produce documents and spreadsheets.
Ability to move within the office and access file cabinets or supplies as needed.
Ability to communicate and exchange accurate information with employees at all levels daily.

Nice To Haves

Supplier Quality Engineering experience in medical device manufacturing.
Experience managing Approved Supplier Lists, supplier qualification records, supplier approval workflows, and related QMS 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.
Experience supporting supplier quality activities across multiple manufacturing locations.
Demonstrated success improving quality process efficiency, standardization, and execution.
ASQ certification, Lean Six Sigma certification, or relevant continuous improvement training.

Responsibilities

Own and manage supplier quality controls, including ASL maintenance, supplier addition requests, supplier approval status, and related supplier qualification controls.
Ensure supplier onboarding, approval, and qualification activities are performed consistently, efficiently, and according to risk-based requirements and QMS procedures.
Govern supplier quality records, approval workflows, supplier status, and documentation to ensure traceability, accuracy, and regulatory compliance.
Establish standardized processes, clear accountability, and appropriate controls for reliable execution and sustained compliance.
Monitor process effectiveness, address execution gaps, and improve adherence, turnaround times, and operational efficiency.
Improve and modernize supplier quality processes to simplify workflows, strengthen controls, and support business needs.
Improve the use and effectiveness of SAP, AssurX, TrackWise, and other applicable quality management platforms.
Partner with Quality Engineering leadership, IT, Quality Systems, and other stakeholders to identify improvement opportunities, define business requirements, and implement sustainable solutions.
Support the transition of manual supplier quality activities to streamlined electronic processes that maintain quality-system controls and regulatory compliance.
Coordinate process changes, system implementations, validation support, and related QMS documentation updates with functional stakeholders.
Ensure improvements are implemented, adopted, and sustained through standardized practices, training, and ongoing monitoring.
Manage standardized monitoring, tracking, and reporting of supplier quality performance, including supplier nonconformances, corrective actions, supplier changes, and other quality indicators.
Ensure supplier quality data is accurate, consistent, and accessible for supplier evaluations, trend analysis, and management decisions.
Collaborate with manufacturing sites to ensure consistent supplier quality processes, controls, and performance monitoring.
Support supplier quality activities across domestic and international manufacturing locations, including onboarding, supplier-related requests, receiving quality issues, and supplier changes.
Partner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams to address process inconsistencies and improve cross-site coordination.
Lead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and operational support.
Provide engineering support for Supplier Change assessments, incoming quality nonconformances, and other supplier quality activities in coordination with Supplier Quality Engineering leadership.
Ensure assigned supplier quality activities are executed in a timely, technically sound, and risk-based manner in accordance with procedures and quality-system requirements.
Partner with other SQE Managers and Operational Procurement to align priorities, balance resources, and resolve supplier quality needs in a timely manner.
Set clear team expectations, develop employee capabilities, and foster accountability, collaboration, and continuous improvement.
Balance daily supplier quality responsibilities with process improvement, cross-functional collaboration, employee development, and manufacturing operations support.

Benefits

Competitive compensation package and benefits and equity program, when applicable.
Medical insurance.
Dental insurance.
Vision insurance.
Life insurance.
AD&D insurance.
Short- and long-term disability insurance.
401(k) with employer match.
Paid parental leave.
Eleven paid company holidays per year.
At least fifteen days of accrued vacation per year, increasing with tenure.
Paid sick time in compliance with applicable laws.
Collaborative teamwork environment with ongoing learning and performance recognition.
Opportunity to contribute to the development of treatments for serious diseases.