LivaNova
Healthcare
SeniorSupplierQualityEngineer
“Senior Supplier Quality Engineer at LivaNova. Skills: Supplier Quality Engineering, Quality Management Systems, Process Validation, Regulatory Compliance. 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 relate”
What You'll Achieve.
changing the trajectory of lives for a new day; ignite patient turnarounds; aspire to alter the course of lives; resolve issues related to product quality, consistent supply and yield; improve quality and reduce cost; ensure continued supply of parts; support business strategy initiatives including cost saving efforts, alternate sourcing, outsourced processes etc.
Industry & Context.
developing cost-effective technical solutions that resolve issues related to product quality, consistent supply and yield; developing approaches to improve quality and reduce cost.
This position may require business travel up to 25% of the time.
What They're Looking For.
Must Have
A Bachelor's Degree in Engineering is required, 8+ Years of Quality or Manufacturing Engineering, 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., 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.
Nice to Have
Experience working in a regulated environment industry such as a FDA medical device manufacturer preferred.
What You'll Do.
Functions as the technical liaison between internal resources (Purchasing
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.
Leads the supplier selection
evaluation and approval process by assessing manufacturing/ technology capabilities
Quality Management System compliance
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
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
Carries out supplier Quality Management System (QMS) and process audits
Collaborates with suppliers on process manufacturing process improvement
process validation (TMV
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
outsourced processes etc.
Provides quality criteria (risk assessment
parameter definition) for receiving inspection
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
Compiles and presents quality data to management as requested and in management
Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter
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.
How You'll Work.
Team & Collaboration
Serves as a core team member on component development teams by providing technical leadership and direction.; Collaborates with suppliers on process manufacturing process improvement, process validation (TMV, IQ, OQ and PQ) and value enhancement opportunities.; Collaborates with Purchasing and procurement functions to support business strategy initiatives including cost saving efforts, alternate sourcing, outsourced processes etc.; Contributes to successful regulatory audits by coordinating back room / front room activities or serving as a subject matter; drive cross-functional internal and external teams to completion of projects within planned timeframes.
Communication Scope
open and honest when communicating among peers and management.
Process & Methodology
Project management skills including the ability to drive cross-functional internal and external teams to completion of projects within planned timeframes.
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