Supplier Quality Engineer

Position Summary This position 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. Functional 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 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 Works with the supplier directly, create corrective action plans to address process failures following the nonconforming product control and CAPA process 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 operations to support the receiving inspection and process failures and ensure timely support, communication and resolution of issues related to supplied parts 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 To ensure successful execution of the responsibilities outlined above, a successful contributor will: Develop and maintain strong, positive business relationships with key internal customers such as Purchasing, Operations, R&D, Project Management Office (PMO), Clinical, Regulatory Affairs (as appropriate) to fulfill the requirements of supplier management activities Gain a full understanding and knowledge of LivaNova devices are designed and manufactured, how they function, how they deliver clinical benefit to determine how the supplied components and services impact the functioning of these devices Maintain and improve technical knowledge in area of expertise to provide value added feedback for supplier management process development, investigations, and product/process changes to ensure the safety and effectiveness of LivaNova devices Collaborate with other areas to achieve Supplier management objectives Knowledge, Skills, and Abilities Required Experience working in a regulated environment industry such as a FDA medical device manufacturer Technical education and experience in an area relevant to LivaNova devices 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 elevate 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 Familiarity with medical industry terminology Proficient in MS Office including Word, Power Point, and Excel This position may require business travel 25% of the time. Education/Experience Required A minimum of a BS in technical area is required (Engineering or other scientific disciplines) 2-3 Years of relevant job experience Compensation & Benefits Target pay: $70,000- $90,000 base and + Annual Incentive Bonus Annual bonus Annual Merit Increases Gym on site Massage Therapist on site On site cafeteria Hot Breakfast and lunches for purchase at discounted prices Paid vacation and personal time Health Insurance and 401K match Training and Advancement Potential Team Based, Supportive Environment Valuing different backgrounds LivaNova values equality and diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination. Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification. #J-18808-Ljbffr