MANAGER SR, QUALITY

St. Jude Medical develops medical technology and services that focus on putting more control into the hands of those who treat cardiac, neurological and chronic pain patients worldwide. The company is dedicated to advancing the practice of medicine by reducing risk wherever possible and contributing to successful outcomes for every patient. Headquartered in St. Paul, MN, St. Jude Medical employs more than 15,000 people worldwide and has four major focus areas that include: cardiac rhythm management, atrial fibrillation, cardiovascular and neuromodulation.

Our success depends on hiring talented people that can make immediate contributions to our growing organization. We currently have the following opening in our Cardiovascular Division:




Description of Work:
Manager Sr, Quality

Position Summary: This position is responsible for developing, establishing and maintaining quality programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency regulations. Specifically, this position will provide Quality Engineering Leadership for the SJM CVD Heart Valve Repair and Replacement Product Families.

Essential Functions:
Provide Quality Engineering leadership in direct support of medical device manufacturing, including:
Management and development of Quality Engineers and Technicians
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.
Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues
Lead in the completion and maintenance of risk analysis
Provides expertise in engineering evaluation and experimentation to determine if product and process capability requirements are being met, and continually improved, within the routine manufacturing process.
Analyzes quality audit findings and recommends modifications in products or standards. Proactively identifies opportunities for system compliance improvement and leads activities to implement improvements.
Assess resource needs to assure that the accurate level of quality support is provided when needed with the competencies needed.
Utilizes Six Sigma and other quality tools to implement process improvements to enhance product quality and reduce process variance by identifying improvement opportunities in regulation compliance, device, process, and system quality, and cost reductions.
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 organization

Qualifications:
4 year degree; industry certification or advanced degree preferred.
Class III or II medical device experience
7+ years in quality management desired with roles of increasing responsibility, impact, and scope within a manufacturing support environment
Six Sigma Black Belt strongly preferred
ASQ Certified Quality Engineer or Manager 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



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St. Jude Medical is an Equal Opportunity Employer

St. Jude Medical is an equal opportunity employer. We value a diverse workforce across all spectrums, including opinion and experience. We seek out creative, conscientious, confident individuals who thrive on taking initiative. In return for those qualities, we offer outstanding compensation, comprehensive benefits and opportunities for professional growth.