Senior Supplier Quality Engineer

LivaNova

Senior Supplier Quality Engineer at LivaNova leading supplier quality initiatives in the medical device industry. Ensuring compliance and effective quality management throughout the supply chain.

Posted 5/28/2026full-timeClear Lake • Texas • 🇺🇸 United StatesSenior💰 $110,000 - $120,000 per yearWebsite

About the role

Key responsibilities & impact

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.

Requirements

What you’ll need

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.

Benefits

Comp & perks

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

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Quality Management System (QMS)supplier process qualificationverification and validationprocess auditsprocess improvementprocess validation (TMV, IQ, OQ, PQ)risk assessmentacceptance samplingstatistical process controllean business systems

Soft Skills

technical leadershipcollaborationcommunicationproject managementproblem resolutionprioritizationplanninginterpersonal skillsresult-orientedteam player

Certifications

Bachelor's Degree in EngineeringISO 13485 complianceMDSAP compliance