Senior Supplier Quality Engineer

The Senior Supplier Quality Engineer functions as the technical liaison between internal resources (Purchasing, R&D, Operations, QE) and suppliers to implement and monitor advanced quality planning in the procurement process for new product introductions and throughout the product life cycle.

This position is available as a Remote opportunity or as a hybrid role based at our site in Clear Lake, TX (Southeast Houston area). It may require business travel up to 25% of the time.

• Lead the supplier selection, evaluation and approval process by assessing manufacturing/technology capabilities, supplier risk levels and Quality Management System compliance.
• Serve as a core team member on component development teams by providing technical leadership and direction.
• Responsible for supplier process qualification, verification and validation activities.
• Review supplier process changes for completeness, accuracy, safety and effectiveness, and manage these changes to ensure continued supply of parts.
• Act as the business process owner for all supplier related nonconformance report (NCR) management, including Material Review Board activities and monitoring their timeliness and effectiveness.
• Carry out supplier QMS and process audits.
• Collaborate with suppliers on process improvement, validation (TMV, IQ, OQ, PQ) and value enhancement opportunities.
• Ensure ongoing compliance with ISO 13485 and MDSAP requirements.
• Collaborate with Purchasing and procurement functions to support business strategy initiatives such as cost saving, alternate sourcing and outsourced processes.
• Provide quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for receiving inspection activities.
• Ensure procedures and processes are updated and consistent with regulatory changes, including development of more efficient QMS processes.
• Compile and present quality data to management and in management review.
• Contribute to regulatory audits by coordinating back‑room/front‑room activities or serving as a subject‑matter expert.
• Support enterprise resource planning controls and develop systems to ensure parts and services are provided by approved sources.
• Perform other duties as required by management.

• Bachelor's Degree in Engineering.
• 8+ years of Quality or Manufacturing Engineering experience in a regulated environment such as a FDA medical device manufacturer.
• Understanding of basic quality engineering principles—including quality leadership, implementation, acceptance sampling, statistical process control, lean business systems, continuous improvement techniques, and risk management.
• Pragmatic, result‑oriented, capable of prioritizing and planning activities with attention to expectations of internal and external stakeholders.
• Good team player who communicates openly and honestly with peers and management and knows when to escalate issues.
• Project management skills with the ability to drive cross‑functional teams to project completion within planned time frames.
• Strong interpersonal skills.
• Record of performance demonstrating metrics meeting objectives during tenure in previous positions.

The annual base salary is estimated at $110,000–120,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience.

• Health benefits – Medical, Dental, Vision
• Personal and vacation time
• Retirement & savings plan (401(k))
• Employee stock purchase plan
• Training & education assistance
• Bonus referral program
• Service awards
• Employee recognition program
• Flexible work schedules