Senior Supplier Quality Engineer

• 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

• 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

Experience working in a regulated environment industry such as a FDA medical device manufacturer preferred

• 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
• discretionary annual bonus