Sr. Supplier Quality Engineer II

Aliso Viejo, CA

$107,700 Per Year
Instant Apply

30+ days ago

Job Description

Title: Sr. Supplier Quality Engineer II
Location: Aliso Viejo, CA (Onsite)
Type: Fulltime
Salary Range: $107,700 $134,600 / Annum + Benefits
Travel: Up to 50% frequent local car travel and occasional domestic air travel

Position Overview
The Sr. Supplier Quality Engineer II will be a key member of the Global Quality organization, responsible for overseeing suppliers and vendors supporting the development, manufacturing, and/or distribution of medical devices and pharmaceutical products.
This role will lead supplier assessments, on-site inspections, supplier performance monitoring, qualification activities, corrective actions, and continuous improvement initiatives. The position will ensure suppliers meet applicable regulatory requirements and company-specific quality standards while driving improvements in product quality, reliability, and on-time delivery.

Key Responsibilities

Partner with cross-functional teams to review and approve requests for new suppliers and determine supplier risk levels and qualification requirements.
Determine supplier classification, risk level, and qualification requirements.
Develop, review, redline, and maintain supplier quality agreements in collaboration with suppliers and Legal.
Maintain the Approved Suppliers List (ASL) in Oracle, including supplier part numbers and service types.
Submit and review changes to supplier classification, risk level, and supplier status.
Issue and manage Supplier Corrective Action Requests (SCARs) to address supplier performance and quality issues.
Maintain supplier quality records and related documentation.
Develop and execute supplier assessment schedules, including leading on-site and remote supplier audits.
Update supplier profiles and documentation following supplier changes.
Analyze supplier performance data, identify improvement opportunities, and drive corrective actions.
Lead the resolution of supplier SCARs.
Continuously improve and optimize supplier management procedures and processes.
Identify and eliminate supplier-related product risks throughout the product lifecycle.
Participate in Quality activities from product concept and development through manufacturing and field use.
Ensure suppliers execute defined product and process requirements and support improvements to those requirements.
Work cross-functionally with internal product teams and suppliers to ensure quality standards are met.
Participate in supplier evaluation and improvement activities.
Support continuous improvement of the Quality Management System (QMS) and related documentation and processes.
Support quality investigations, initiatives, and organizational projects as needed.

Required Qualifications
Experience

8+ years of relevant professional experience.
Experience in Supplier Quality / Supplier Management involving manufactured products.
Experience performing quality system and supplier audits is highly desirable.
Experience with Quality Management Systems (QMS) .
Experience with Root Cause Analysis and Corrective Action .

Regulatory & Quality Knowledge

Working knowledge of: 21 CFR Part 210, 21 CFR Part 211, Annex 1, 21 CFR Part 820, ISO 13485, ISO 14971
Strong knowledge of regulations applicable to pharmaceutical and medical device manufacturing .
Understanding of supplier qualification, supplier risk management, audits, corrective actions, and quality compliance.

Skills & Abilities

Strong documentation skills with excellent attention to detail and accuracy.
Strong written and verbal communication skills.
Ability to work effectively and collaboratively in a cross-functional team environment.
Strong analytical and problem-solving skills.
Ability to manage supplier quality issues and drive corrective actions through resolution.
Ability to travel up to 50% for supplier assessments and quality activities.

Preferred Qualifications

ASQ certifications preferred , including:
CQA Certified Quality Auditor
CBA
CQE Certified Quality Engineer
CSSBB Certified Six Sigma Black Belt

Numbers & Facts

Location

Aliso Viejo, CA

Skills

American Society for Quality (ASQ)unmatched
Analysis Skillsunmatched
Auditingunmatched
Biotech and Pharmaceuticalunmatched
Certified Quality Engineer (CQE)unmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Corrective Actionunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Detail Orientedunmatched
Distribution Servicesunmatched
Documentationunmatched
ISO (International Organization for Standardization)unmatched
Legalunmatched
Manufacturingunmatched
Medical Equipmentunmatched
Oracleunmatched
Performance Analysisunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Process Improvementunmatched
Product Lifecycleunmatched
Quality Assuranceunmatched
Quality Engineeringunmatched
Quality Managementunmatched
Quality Metricsunmatched
Record Keepingunmatched
Regulationsunmatched
Regulatory Requirementsunmatched
Requirements Managementunmatched
Riskunmatched
Risk Managementunmatched
Root Cause Analysisunmatched
Six Sigma Black Beltunmatched
Six Sigma Certificationunmatched
Supplier Optimizationunmatched
Time Managementunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Managementunmatched
Vendor/Supplier Planningunmatched
Vendor/Supplier Quality Managementunmatched
Vendor/Supplier Selectionunmatched
Willing to Travelunmatched
Writing Skillsunmatched

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