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Sr. Supplier Quality Engineer II

Trident Consulting
  • 🇺🇸 United States
  • Hybrid
  • Senior
  • 1 day ago
  • Oracle
  • Risk Management
1 day ago
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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


Sr. Supplier Quality Engineer II · Trident Consulting

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