Nationwide Executive Recruitment From FPC

(F-O-R-T-U-N-E PERSONNEL CONSULTANTS)

You'll Value The Experience!

The Principal Supplier Quality Engineer will work closely with finished medical device manufacturers and business units to ensure product quality meets company and FDA requirements. Work closely with strategic sourcing and new business development with new partners. Play a lead role in corporate policy development and training for matters involving finished medical device manufacturers

• Provide in depth process quality engineering support with respect to process validation activities as well as post launch supplier quality tasks including manufacturing issue resolution.
•  Have established competencies in project management and appropriate experience in supply management policy and process development, including new process rollout, implementation, training and follow-up, across the entire corporation.
• Perform FMD supplier assessments and due diligence activities via on-site assessments and reporting.
• Perform product, process and system assessments as required, manage assessment and supplier corrective actions, implementation and effectively
• Apply risk assessments, product reliability methods to ensure product meets functional and safety requirements.
• Review/approve technical instructions (DFU and IFU's) for compliance to internal and external requirements.
• Work in support or as lead contributor on Alliance partner relationship and management policy development and training

Qualifications

• BS in Mechanical/Manufacturing Engineering or other Technical discipline required. Masters a plus.
• Must have excellent communication and interpersonal skills
• Ability to manage multiple projects with a proven track record of meeting deadlines.
• Ability to develop strong cross-functional relationships
• Knowledge of QSR and FDA design/process control requirements is required.
• Working knowledge of ISO requirements and the MDD are essential.
• 9 plus years of experience in the medical device industry with 2-4 years of medical device assessment experience with an emphasis on product focused risk based assessments, preferred, not required.
• Strong analytical skills with the application of statistical methods resulting from Risk Analysis is required.
• 2D/3D modeling knowledge a plus.
Ability to travel up to 30%, to suppliers primarily domestic, but some international.
Proven experience in writing technical reports, business correspondence and procedure manuals.
Demonstrates proficiency to work with mathematical concepts such as probability and statistical inferences and fundamentals of plane and solid geometry.

Proven computer literacy with§ the Microsoft Office Suite