Quality Systems Manager

Job Description

Careers That Change Lives In this exciting role as a Supplier Quality Engineering Manager, you will have responsibility for leading a team of Supplier Quality Engineers located in North Haven, CT. This Supplier Quality Engineering team provides support for product development programs for new medical devices. The team will have responsibility for developing the strategies that drive component quality, product quality and continuous improvement. The Supplier Quality Manager and team shall partner with the supplier to manage new and existing supplied product performance and improvement activities. The Supplier Quality Manager leads the oversight of supplied products, ensuring conformance to purchased materials or finished devices requirements and management of nonconforming product in compliance to Medtronic Purchasing and Supplier Controls, FDA, and international requirements and Quality System Regulations. Our Global Quality Strategy is rooted in the Medtronic Mission and our Quality Policy. Being a 'trusted partner' means always putting patient safety first, upholding product quality, and maintaining the highest ethical standards in our business relationships and programs. A Day in the Life

• Manages a team of Supplier Quality Engineers that are responsible for ensuring delivery of quality parts, materials, and services.
• Manage performance, develop talent, engagement, and inclusion, communicate business and operational developments, plan, prioritize and/or direct the responsibilities of direct reports.
• Responsible for mentoring, developing and coaching staff in alignment with performance expectations and defined objectives.
• Ensure the prioritization of strategic and department level initiatives to include team member assignment, defining performance goals and targets and conducting performance reviews.
• Develop/maintain monitoring systems to track supplier & team performance (training, nonconformances, open actions, supplier changes, supplier quality improvement programs, goals, etc.)
• Leads cross-functional teams of engineers and manufacturing functions to investigate and resolve supplier-related quality or compliance issues discovered during incoming inspection and/or production.
• Lead team in corrective/preventive actions to resolve supplier-related issues (e.g., nonconformances, CAPA activities, audit findings, complaint investigations, etc.).
• Serves as a Supplier CAPA (sCAPA) Board member and/or sCAPA Board Chair.
• Manage, coordinate, and perform supplier quality audits

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

Nice to Have

• Practical knowledge in leading and managing the execution of processes, projects and tactics within Supplier Quality Engineering.
• Advanced knowledge and skills within a Supplier Quality Engineering discipline with understanding of the impact of work on other areas of the organization.
• Bachelor’s degree in Engineering, Science or related Technical Field and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.
• MBA, Master’s in Engineering, Science or related Technical Field
• ASQ CQE, CQA and/or CSQP certification
• First Time Quality Coach (FTQ) / Six Sigma/ DFSS / Lean Green Belt or Black Belt certified
• Strong communication, organizational and project planning skills
• Demonstrated track record of effectively influencing and negotiating with others and leading effective/successful change initiatives
• Strong knowledge of metrology & measurement techniques; statistical analysis (Cpk, standard deviation, etc) in Minitab, measurement uncertainty, GD&T, Gauge Repeatability & Reproducibility

About Medtronic
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
Physical Job Requirements
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)

Additional Information

• Posting Date: Feb 24, 2022
• Travel: Yes, < 25 % of the Time