Rice Creek, Minnesota, United States
▾3 additional locations
Louisville, Colorado, South Carolina, Irvine, California
This position has the responsibility and authority to author and execute protocol and reports for design control evidence related to Medtronic Operations initiated supplier changes. Collaborates with cross-functional teams to ensure changes follow quality system requirements. Devises and implements strategy for inspecting, testing and evaluating product acceptance for assigned supplier changes. Performs statistical analysis to assess the capability and compliance of products. Ensures that corrective measures meet acceptable quality 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.
Day in the life:
• Assess and coordinate change control strategy with the project manager.
• Communicate design control requirements and deliverables to suppliers.
• Prioritize assigned qualifications with timeline commitments.
• Assist in creation of standard work to optimize qualification efforts across multiple quality systems.
• Assist in creation of metrics to help measure qualification team success.
• Supports qualification engineer with project issue communication and resolution.
• Partner cross functionally with Project Leaders, Quality, Reliability, Design and Regulatory to continuously improve execution.
• Assist the development of project qualification of supplier strategies.
• Lead execution of all characterization and qualification activities.
• Author and/or review IQ/Characterization/OQ/PQ protocols and reports.
• Coordinate and schedule builds, testing and reports to support qualification strategy (e.g. leachable/extractable testing, bioburden / endotoxin testing, manufacturing assessments, qualification inspection).
• Support transition of receiving inspection to supplier owned quality program.
• Support supplier and Medtronic test method validation (TMV) program.
• Train, coach and assist suppliers with pFMEA and process control plans.
• Perform statistical analysis and analyze results.
• Ensure full compliance to quality policy requirements.
• Work with cross-functional teams (including supplier resources) to drive continuous improvement, root cause and final resolution of supplier related opportunities or issues.
• Frequent interaction with internal or external contacts at various organizational levels concerning ongoing operations or changes relating to processes or programs.
• Participates in briefings with internal and external contacts.
• All activities must be performed in compliance with the Quality System.
• Performs duties in compliance with environmental, health and safety related site rules, policies or governmental regulations.
• All other duties as assigned.
• Travel requirement: less than 25%
Must Have: Minimum Qualifications
- Bachelor’s Science degree in Engineering, Physics, Materials, Industrial Technology or other equivalent technical degree.
- 7+ years of experience with Bachelors Degree OR 5+ years of experience with Masters Degree
Nice to Have
• Experience in medical device industry
• Knowledge of regulatory environments (i.e.: ISO, FDA-GMP, etc.) or equivalent
• Advanced Statistical analysis
• Proficient in use of Minitab and MS Office (Visio, Excel, PowerPoint and Word)
• Ability to identify, analyze and solve problems with minimal direction and make decisions with confidence. Superior communication skills, both oral and written.
• Strong attention to detail and accuracy. Ability to successfully balance and prioritize multiple ongoing projects/tasks (Project Management skills).
• High degree of initiative and self motivation. Strong analytical skills and the ability to solve problems through analytical reasoning.
• Strong technical writing skills
• Travel may be required.
• Experience navigating projects across multiple quality systems
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 above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
The physical demands described within the Day in the Life 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.
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