Supplier Quality Engineering Manager – Supplier Controls

Penumbra, Inc.

. Own and manage supplier quality control processes, including Approved Supplier List (ASL) maintenance, supplier addition requests, supplier approval status, and supplier qualification controls .

Posted 11/12/2026full-timeAlameda • California • United StatesSeniorLead💰 $145,000 - $214,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Supplier Quality Management, including supplier qualification, onboarding, and performance monitoring, while ensuring compliance with ISO 13485 and FDA QMSR standards. Proven ability to lead quality engineering teams and drive continuous improvement in operational processes and supplier quality controls.

Highest-signal resume keywords

Supplier Quality ManagementISO 13485 ComplianceFDA QMSR KnowledgeQuality Engineering LeadershipERP Quality Management Systems

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier QualificationSupplier OnboardingNonconformance ManagementQuality Process ManagementOperational Execution Improvement

Soft Skills

Organizational SkillsAnalytical SkillsCommunication SkillsCross-Functional Collaboration

Tools & Technologies

SAPAssurXTrackWiseElectronic Quality Management Systems

Industry Keywords

Regulated Manufacturing EnvironmentSupplier Quality ControlQuality Management System ProceduresSupplier Performance Monitoring

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Own and manage supplier quality control processes, including Approved Supplier List (ASL) maintenance, supplier addition requests, supplier approval status, and supplier qualification controls
Ensure supplier onboarding, approval, and qualification activities comply with risk-based requirements and quality management system procedures
Govern supplier quality records, approval workflows, supplier status, and documentation for traceability, accuracy, and regulatory compliance
Establish standardized processes, accountability, and controls for reliable execution and sustained compliance
Monitor process effectiveness, address execution gaps, and improve process adherence, turnaround times, and operational efficiency
Modernize supplier quality processes and workflows
Improve use of SAP, AssurX, TrackWise, and other quality management platforms
Partner with Quality Engineering leadership, IT, Quality Systems, and cross-functional stakeholders on improvements and system solutions
Transition manual activities to electronically managed processes
Coordinate process changes, system implementation, validation support, and QMS documentation updates
Monitor, track, and report supplier quality performance, nonconformances, corrective actions, supplier changes, and other quality indicators
Ensure supplier quality data supports evaluations, trend analysis, and management decisions
Collaborate with domestic and international manufacturing sites on consistent process application and supplier quality activities
Partner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams
Lead, coach, and develop a team of Supplier Quality Engineers
Provide engineering support for Supplier Change assessments and incoming quality nonconformances
Align priorities and resources with other SQE Managers and Operational Procurement
Establish team expectations, develop employee capabilities, and foster accountability and continuous improvement

Requirements

What you’ll need

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 (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
Ability to move between buildings and floors
Ability to remain stationary and use a computer or other standard office equipment for an extensive period each day
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 on a daily basis

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Life insurance
AD&D insurance
Short-term disability insurance
Long-term disability insurance
401(k) with employer match
Paid parental leave
Eleven paid company holidays per year
Minimum of fifteen days of accrued vacation per year, increasing with tenure
Paid sick time in compliance with applicable law(s)
Competitive compensation package
Equity program, when applicable
Collaborative teamwork environment
Learning opportunities
Performance rewards