Quality Engineering Manager

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

• Provide leadership in direct support of medical device manufacturing.
• Management and development of Quality Engineers and Technicians.
• Own the activities of the Post-Production Quality Engineering team.
• Ensure successful planning, management and execution of area projects.
• Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization.
• Passionately find opportunities to assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Purposefully identify and lead activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
• Define and implement Process Control & Monitoring systems for KPIV and KPOV throughout the product lines – Critical Parameter Management.
• Provide influential peer leadership with international partner site to drive quality improvements.
• Approve/author experimental plans, protocols and reports, including supporting teams on appropriate statistical analysis techniques.
• Identify Quality Initiatives and lead multi-functional teams to complete them.
• Provide enthusiastic, diligent, and fact-based communication to Sr. Management team, peers and team.
• Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
• Lead the Nonconformance and Real-time data management portions of the quality System.
• Be an effective member of the cross-departmental Functional Management Team to foster continuous quality compliance, cost, and improvements.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.

• 4 year degree; industry certification or advanced degree, electrical or mechanical engineering preferred.
• Class III or II medical device experience (catheter experience preferred).
• 5+ years in quality desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment.
• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Deep understanding of risk management in design, manufacturing and post-market surveillance.
• Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
• Strong project management and people leadership skills required.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback to build positive relationships and improve business results.
• Work effectively within a team in a dynamic environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong interpersonal skills, planning, and follow-up skills and ability to hold others accountable.

• Lean Six Sigma Black Belt strongly preferred.
• ASQ Certified Quality Engineer strongly preferred (CQE, CRE).
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to travel approximately 5-10%, including internationally.

Abbott