Job ID: JOB_ID_27
Role Overview
The Senior Supplier Quality Engineer for External Manufacturing is a critical role designed to ensure the highest standards of product quality and regulatory compliance within our global supply chain. Located onsite in Irvine, California, this long-term contract position offers a unique opportunity to lead quality initiatives, manage external supplier relationships, and drive continuous improvement across complex manufacturing processes. As a senior member of the quality team, you will be responsible for bridging the gap between internal strategic goals and external manufacturing execution, ensuring that every component and finished product meets rigorous safety and performance specifications.
Key Responsibilities and Strategic Impact
- Provide expert, risk-based Quality Assurance (QA) guidance to cross-functional teams, making high-stakes decisions regarding product quality and compliance.
- Lead comprehensive investigations into supplier-related nonconformances, utilizing advanced root cause analysis (RCA) methodologies to identify systemic issues.
- Oversee the development and implementation of Corrective and Preventive Actions (CAPA), ensuring that suppliers address the heart of quality failures to prevent recurrence.
- Manage the Approved Supplier List (ASL) and conduct rigorous qualification audits for new external manufacturing partners.
- Draft, negotiate, and maintain Quality Agreements that clearly define the standards and expectations for external manufacturing operations.
- Collaborate with Procurement, R&D, and Supply Chain departments to identify potential risks in the supply chain and develop robust mitigation strategies.
- Ensure all activities are performed in strict adherence to Current Good Manufacturing Practices (cGMP) and internal Quality Management System (QMS) protocols.
- Monitor supplier performance metrics, providing regular reports to senior leadership on quality trends and areas for operational enhancement.
Technical Qualifications and Experience
- Extensive experience in Supplier Quality Engineering, specifically within an external manufacturing or contract manufacturing environment.
- Deep knowledge of ISO standards and FDA regulations, with a focus on cGMP compliance within the healthcare or medical device sectors.
- Proven track record of managing complex NC/CAPA processes from initiation through to effectiveness verification.
- Strong proficiency in risk management tools, including FMEA (Failure Mode and Effects Analysis) and risk-based decision-making frameworks.
- Experience with Electronic Quality Management Systems (eQMS) and ERP platforms for tracking supplier performance and documentation.
- Ability to interpret technical drawings, specifications, and manufacturing process flows to identify potential quality bottlenecks.
Professional Skills and Cultural Fit
- Exceptional communication skills, with the ability to influence external partners and internal stakeholders at all levels of the organization.
- Strong analytical mindset, capable of distilling complex data into actionable quality improvements.
- Adaptability to a fast-paced, evolving business environment where priorities may shift based on market demands or regulatory changes.
- Leadership qualities that foster a culture of quality and accountability across the supply chain.
- Commitment to continuous learning and staying abreast of industry trends in manufacturing technology and quality science.
Location and Work Environment
This position is based onsite in Irvine, CA. Irvine is a premier hub for medical device and high-tech manufacturing, offering a vibrant professional community and a high quality of life. The role requires a professional who thrives in a collaborative, hands-on environment and is comfortable working directly on the manufacturing floor as well as in corporate office settings. As a long-term contract engagement, this role provides stability while allowing for significant professional growth within a leading-edge manufacturing ecosystem.
Special Requirements
Onsite in Irvine, CA; Long Term Contract; Domain: External Manufacturing; Requires cGMP compliance knowledge.
Compensation & Location
Salary: $145,000 – $195,000 per year (Estimated)
Location: Irvine, CA
Recruiter / Company – Contact Information
Recruiter / Employer: Valzo Soft Solutions LLC
Email: prince@valzosoft.com
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