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.
Location & Travel
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.
Job Duties
- 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.
Minimum Qualifications
- 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 timeframes.
- Strong interpersonal skills.
- Record of performance demonstrating metrics meeting objectives during tenure in previous positions.
Pay Transparency
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.
Benefits
- 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