Location & Travel- This position is based at our site in Clear Lake, TX (Southeast Houston area)
- This position may require business travel up to 25% of the time.
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, identifying and developing cost-effective technical solutions that resolve issues related to product quality, consistent supply and yield, and developing approaches to improve quality and reduce cost.
Job Duties- Leads the supplier selection, evaluation and approval process by assessing manufacturing/ technology capabilities, supplier risk levels, Quality Management System compliance, etc.
- Serves as a core team member on component development teams by providing technical leadership and direction. Responsible for supplier process qualification, verification and validation activities
- Reviews supplier process changes for completeness, accuracy, and safety/effectiveness including the identification of all impacts and timely management of these changes with to ensure continued supply of parts
- Acts as business process owner for all supplier related nonconformance report (NCR) management system, including material review board (MRB) activities, monitoring the timeliness and effectiveness of the system and activities;
- Carries out supplier Quality Management System (QMS) and process audits
- Collaborates with suppliers on process manufacturing process improvement, process validation (TMV, IQ, OQ and PQ) and value enhancement opportunities.
- Ensures ongoing compliance per ISO 13485 and MDSAP requirements
- Collaborates with Purchasing and procurement functions to support business strategy initiatives including cost saving efforts, alternate sourcing, outsourced processes etc.
- Provides quality criteria (risk assessment, acceptance criteria, sample size, parameter definition) for receiving inspection activities;
- Ensures that procedures and processes are maintained and updated to be consistent with regulatory changes including the development of more efficient QMS processes and global QMS processes;
- Compiles and presents quality data to management as requested and in management review;
- Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter expert;
- Supports enterprise resource planning controls and develop systems to ensure that parts and services are provided by approved sources
- Performs other duties as may be required by management.
Minimum Qualifications- A Bachelor's Degree in Engineering is required
- 8+ Years of Quality or Manufacturing Engineering
- Experience working in a regulated environment industry such as a FDA medical device manufacturer preferred.
- Understanding of basic quality engineering principles including, but not limited to: quality leadership, implementation, acceptance sampling, statistical process control, lean business systems and other continuous improvement techniques, and risk management.
- Pragmatic and result-oriented: capable to prioritize and plan activities with specific attention to understand expectations of internal personnel and external stakeholders.
- Good team player: open and honest when communicating among peers and management. Resolves most issues with peers, but understands what issues are important to escalate to management.
- Project management skills including the ability to drive cross-functional internal and external teams to completion of projects within planned timeframes. Strong interpersonal skills.
- Sustained record of performance during tenure in previous position as shown through consistency with which metrics in their areas of responsibility meet performance objectives as established in Management Review and a track record of implementing improvements.
Pay Transparency- A reasonable estimate of the annual base salary for this position is $110,000 - 120,000 plus discretionary annual bonus. Pay ranges may vary by location and are awarded based on experience.
Employee benefits include:- Health benefits - Medical, Dental, Vision
- Personal and Vacation Time
- Retirement & Savings Plan (401K)
- Employee Stock Purchase Plan
- Training & Education Assistance
- Bonus Referral Program
- Service Awards
- Employee Recognition Program
- Flexible Work Schedules
