Oversee and manage the acquired manufacturing site as a quality representative. Initiate and manage changes needed to address Quality System and process gaps to mitigate risk. Integrate necessary quality system functions into Medtronic Quality system.
•Coach and guide contractors and team members to manage all remediation related activities, post market monitoring and risk management
•Lead, support and facilitate any internal and external audits
•Manage project related deliverables, mitigate schedulerisks and present to management as needed
•Up to 25% of travel could be involved with the role.
Responsibilities may include the following and other duties may be assigned.
- Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
- Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
- Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
- Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
- Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
- May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
- Ensures that suppliers deliver quality parts, materials, and services.
- Qualifies suppliers according to company standards and may administer a Certified Supplier Program in receiving inspection to ensure cost effectiveness.
- Monitors parts from acquisition through the manufacturing cycle and communicates and resolves supplier-related problems as they occur.
- Develops and prioritizes an auditing schedule to ensure that designated suppliers are audited on a regular basis to ensure good manufacturing practices (GMP) and quality standards are met.
- Evaluates suppliers' internal functions to assess their overall performance and provides feedback in assessment of their operation.
- Some individuals may have responsibilities that include Pre-Market Supplier Quality and duties may include: Provides Pre-Market Quality Engineering support to New Product Development (NPD) working in partnership with the Component Engineering and Post-Market Supplier Quality Teams, to deliver quality parts, materials, and services, prevent defects, and allow Medtronic to provide customers with the highest quality and reliable products.
- Provides technical guidance and quality compliance for Supplier Quality engagement throughout the NPD lifecycle on newly qualified parts from NPD and implementing strategies for driving product quality and continuous improvement, ensuring purchased products and components are manufactured and qualified in accordance to applicable industry standards, regulatory requirements, and customer requirements.
- Collaborates with Component Engineers to develop and deliver the Product Acceptance Sampling Strategy, Approved Supplier List coordination, Supplier Owned Quality deployment, and Control Plans for new products.
- Define Receiving Inspection requirements as required and associated test method validation for all internal Medtronic Test Methods.
Must Have: (Minimum Requirement)
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h) ( 4)(iii)(A)
- Minimum of 7 years relevant Quality Engineering experience, or advanced degree
- Minimum of 5 years prior relevant Quality Engineering experience.
Nice to Have: (Preferred Qualifications)
- Prior experience with leading and integrating acquired sites into the quality system and performing remediation
- Excellent leadership skills, ability to identify and hire talent to support the business needs
- Good communication and presentation skills, especially with higher management on business-critical initiatives