Engineer, Quality (Supplier)

Job Title: Engineer, Quality (Supplier)

Role Level: Individual Contributor

Supervisor/Manager Title: Manager, Supplier Quality Assurance

Job Location & Environment: Irvine, CA - Corporate Office

Job Description Summary: Responsible for ensuring the quality of supplied components, materials and services, leading supplier audits, managing supplier performance, and driving continuous improvement within the supply chain to meet regulatory and quality standards.

Job Responsibilities:

• Support and maintain a risk-based supplier management program aligned with ISO 13485, FDA QMSR/21 CFR Part 820, EU MDR, ISO 14971, and internal QMS requirements.
• Review supplier capabilities, certifications, and quality management systems and lead the qualification and approval of new suppliers.
• Support supplier selection and development activities for R&D projects and ongoing manufacturing operations.
• Plan, conduct and report supplier audits, ensuring compliance with applicable regulatory requirements and internal procedures; drive closure of audit findings.
• Develop, negotiate, and maintain Supplier Quality Agreements, clearly defining quality expectations, responsibilities, change notification requirements, and documentation standards.
• Maintain supplier records in accordance with JenaValve procedures. 
• Work with cross-functional team to conduct periodic supplier re-evaluation, supplier scorecards, quality, and business risk reviews, and escalation of adverse supplier trends.
• Monitor supplier performance, identify opportunities to improve supplier management processes and supplier performance, and implement corrective actions to drive continuous improvement and compliance.
• Lead investigations of supplier-related nonconformances.
• Support complaint investigation and field corrective actions related to supplier issues.
• Lead timely review and execution of supplier proposed change requests or changes to be implemented at the supplier at JenaValve’s request
• Collaborate with suppliers to drive closure of Supplier Corrective Action Requests (SCARs), including verification of effectiveness and prevention of recurrence.
• Partner with cross-functional team to define Receiving Inspection requirements as required and associated test method validation as applicable.
• Supports receiving inspection activities.
• Perform other related duties or tasks as assigned by Manager.

Required Education and Experience:

• Bachelor of Science degree in Mechanical or Biomedical Engineering (or equivalent engineering degree).
• 1-3 years medical device Quality/Regulatory experience in supplier quality, quality engineering or manufacturing.
• Working knowledge of process validation, nonconformance resolution, CAPA, risk management and continuous improvement.
• Lead Auditor certification is a plus.
• Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.

Skills and Abilities Required for This Job:

• Must be able to work effectively and collaborate within cross-functional teams.
• Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel.
• Must have strong project management and documentation skills.
• Must take initiative and have the ability to conduct hands-on work.
• Must possess the ability to handle multiple tasks with high attention to detail.

Physical Requirements:

• Prolonged periods of sitting at a desk or in meetings (often most of the workday).
• Frequent computer use requiring repetitive hand/finger motion (typing, mouse, data entry)
• Periodic travel may be required.