VP of Quality & BPI for a medical products and components

Strong, perceptive leader needed to lead strategic Quality and Business Process Improvement(BPI ) initiatives companywide following new company aquisition. Will champion corporate ideals bringing staff forward into a positive, contributory state through your personal influence and guidance, setting processes, mentoring staff, solving problems, etc.
Will focus on ensuring safe, cost effective products reach the marketplace. Key initiatives will include driving consistency and effectiveness of quality improvement and measurement processes globally, creating and leveraging a new global product quality scorecard and using it to drive activities on all products, and taking process and quality documentation global.NEEDED: Strong Leadership skills, Six Sigma, knowledge of FDA and manufacturing operations, able to set BPI, business process improvement for implementation companywide.
REQUIREMENTS
Requirements for the position:* BS degree and 8-10 years overall experience, strong Quality and BPI background.* 4-5 years of management experience, with great people skills able to inspire and motivate others, insightful in conflict resolution, a capable change agent, a mentor, passionate about Quality! Must be able to use your personal influence to achieve buy-in, overcome obstacles.* Strong ability and vision to set up global quality and BPI initiatives, processes and programs and champion initiatives throughout the company and develop support organization, create and leverage quality scorecard.* Strong leadership in lean techniques, six-sigma and other process improvement methodology for quality and productivity. Six-Sigma Black Belt desired.* Seeking successful development of BPI, business process improvement, especially as it relates to establishing processes not presently being expoited for new company acquisitions. Must be capable of initiating processes eliminating risk of regulatory issues or unsafe product reaching the field. Establish common quality system meeting global quality and regulatory standards companywide across multi-sites.* Provide leadership and assistance in driving CARPA (Corrective and Preventive Actions) establishing root cause analysis and long term solutions, trend analysis, corrective action.* Successful management of compliance audits (FDA, SGS, Customer and Internal audits). Demonstrated competency with quality tools such as flowcharts, design of experiments, statistical analysis (minitab capability preferred), fishbone diagrams. In depth knowledge for international and domestic industry standards e.g. FDA, U/L, CE Mark process.* Experience in medical devices, medical components and/or minimally invasive surgical equipment highly desired.* Must have good project management and people skills providing technical expertise, coaching, leading team building and performs evaluation for the direct reports.For confidential consideration please email your current resume to:
Sheila Schultz [Click here for email]