We are seeking an experienced, high caliber Quality Engineering Manager. This position is responsible for developing, establishing and maintaining quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations.
Each employee can make a difference at St. Jude Medical and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
Impact this role will have on St. Jude Medical:
* Provide Quality Engineering leadership in direct support of medical device manufacturing, including:
* Management and development of Quality Engineers and Technicians
* Manage the activities of the Post-Production Quality Engineering team
* Provide Quality Engineering Body of Knowledge guidance and leadership to department and organization
* Aggressively identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
* Aggressively identify and manage activities related to adding value to the organization through risk reduction, cost improvement, and budgetary responsibility.
* Define and implement superior 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 proactive quality improvements
* Identify Quality Initiatives and lead cross-functional teams to complete them
* Provide proactive, 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.
* Oversee 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 proactive improvements.
* Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
* Be a champion of Quality, Six Sigma, Lean and disciplined problem solving throughout the organ
* Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
* Hires and retains a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. Maintains a safe and professional work environment.
* Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
* Performs other related duties and responsibilities, on occasion, as assigned.
Your experience(s), education and knowledge will further expand St. Jude Medical’s marketplace success:
* 4 year degree; industry certification or advanced degree preferred.
* Class III or II medical device experience
* 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired
* 3-5 years in a supervisory/leadership role.
* Six Sigma Black Belt strongly preferred
* ASQ Certified Quality Engineer strongly preferred
* Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment
* Ability to travel internationally to support international manufacturing sites
* 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)
* Demonstrated and impactful strong project management and people leadership skills required
* Experience working in a broader enterprise/cross division business unit model preferred.
* 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 respectfully to build positive relationships and improve business results.
* Ability to work effectively within a team in a fast-paced changing 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 organizational, planning, and follow-up skills and ability to hold others accountable.
* Ability to travel approximately 25%, including internationally.
* Ability to maintain regular and predictable attendance.
Your preferred qualifications and education:
* 4 year degree; industry certification or advanced degree.
* Six Sigma Black Belt
* ASQ Certified Quality Engineer
* Experience working in a broader enterprise/cross division business unit model.
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**Job:** **EN-Quality Assurance Engineering*
**Title:** *Quality Engineering Manager*
**Location:** *Minnesota-Minnetonka*
**Requisition ID:** *1500016I*
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