Supplier Quality Engineer

LivaNova•Houston, TX

17h•$85,000 - $100,000•Onsite

About The Position

As a global medtech company, we are driven by our Vision of changing the trajectory of lives for a new day and our Mission to create ingenious solutions that ignite patient turnarounds. Our relentless commitment to patients and strong legacy of innovation in healthcare are the foundation of our future. If you're looking for a new chance, a new beginning, a new trajectory, LivaNova is where your talent can truly thrive. Join our talented team members worldwide to become a pioneer of tomorrow—because at LivaNova, we don’t just treat conditions — we aspire to alter the course of lives. Location & Travel This position is based at our site in Clear Lake, TX (Southeast Houston area) This position may require business travel 25% of the time. The 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.

Requirements

A Bachelor's Degree in Engineering is required
3+ 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.

Responsibilities

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.