Senior Supplier Quality Engineer

Job Duties

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;

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

Minimum Qualifications

• 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.