Supplier Quality Engineering Manager – Supplier Controls

Penumbra•Alameda, CA

1d•Onsite

About The Position

Penumbra is seeking an experienced Supplier Quality Engineering Manager to oversee and continually improve supplier quality processes and controls that support manufacturing operations and regulatory compliance. The manager will own supplier quality processes including Approved Supplier List (ASL) management, supplier onboarding and qualification controls, and supplier performance monitoring. The role ensures processes are executed consistently and in compliance with quality management system requirements while improving efficiency, standardization, and operational effectiveness. The manager will modernize supplier quality processes and systems by working across functions and using enterprise platforms to simplify workflows and strengthen controls. They will lead a dedicated team of Supplier Quality Engineers supporting supplier quality operations and Operational Procurement across multiple manufacturing sites. Success requires supplier quality engineering expertise, practical quality-process management, people leadership, and a continuous improvement mindset. The position is based in Alameda, California, and requires working on site. Work may take place in general office, laboratory, and cleanroom environments, with business travel ranging from 0% to 25%. The role may involve exposure to blood-borne pathogens and requires occasional lifting and moving of up to 25 pounds, movement between buildings and floors, and extended periods using a computer or standard office equipment. The annual base salary range is $138,000 to $203,000. Penumbra offers a competitive compensation package and, when applicable, benefits and equity. Eligible employees may receive medical, dental, vision, life, AD&D, short- and long-term disability insurance, a 401(k) with employer match, paid parental leave, eleven paid company holidays per year, at least fifteen accrued vacation days per year (increasing with tenure), and paid sick time in accordance with applicable law. The company describes its environment as collaborative, with ongoing learning and performance rewards, and offers the opportunity to contribute to therapies for serious diseases.

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 processes, including supplier qualification, onboarding and approval, supplier controls, 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 up to 25 pounds, move between buildings and floors, remain stationary and use a computer or standard office equipment for extended periods, and perform the described office-related tasks and communication.

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 control processes, including ASL maintenance, supplier addition requests, supplier approval status, and supplier qualification controls.
Ensure supplier onboarding, approval, and qualification activities are carried out consistently, efficiently, and in accordance with risk-based requirements and QMS procedures.
Maintain governance of supplier quality records, approval workflows, supplier status, and supporting documentation to ensure traceability, accuracy, and regulatory compliance.
Establish standardized processes, clear accountability, and controls that support reliable execution and sustained compliance.
Monitor process effectiveness, address execution gaps, and improve process adherence, turnaround times, and operational efficiency.
Modernize supplier quality processes to improve efficiency, simplify workflows, strengthen controls, and support business needs.
Improve the use and effectiveness of enterprise systems, including SAP, AssurX, TrackWise, and other applicable quality management platforms.
Partner with Quality Engineering leadership, IT, Quality Systems, and cross-functional stakeholders to identify improvements, define business requirements, and implement sustainable solutions.
Support the transition of manual supplier quality activities to streamlined electronic processes while maintaining quality system controls and regulatory compliance.
Coordinate process changes, system implementation activities, validation support, and QMS documentation updates with functional stakeholders.
Ensure process improvements are implemented, adopted, and sustained through standardized practices, training, and ongoing monitoring.
Manage standardized processes for monitoring, tracking, and reporting supplier quality performance, including supplier nonconformances, corrective actions, supplier changes, and other established quality indicators.
Ensure supplier quality data is accurate, consistent, and accessible for supplier evaluations, trend analysis, and management decision-making.
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 supplier onboarding, supplier-related requests, receiving quality issues, and supplier changes.
Partner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams to address inconsistencies and improve cross-site coordination.
Lead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and operational support activities.
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 timely, technically sound, risk-based, and compliant 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 day-to-day supplier quality responsibilities with process improvement, cross-functional collaboration, employee development, and manufacturing operations support.

Benefits

Competitive compensation package and equity program, when applicable.
Medical insurance for eligible employees.
Dental insurance for eligible employees.
Vision insurance for eligible employees.
Life insurance for eligible employees.
AD&D insurance for eligible employees.
Short- and long-term disability insurance for eligible employees.
401(k) with employer match for eligible employees.
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 rewards.