At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

PREFERRED QUALIFICATIONS:

• Project management skills
• Experience in corrective actions - especially corrective and preventive actions (CAPAs)
• Lean manufacturing experience, Define, Measure, Analyze, Improve and Control (DMAIC) problem-solving experience
• Experience of medical manufacturing and Good Documentation Practices (GDP)
• Experience of internal and external audits
• Experience of cell operating systems (COS)
• SAP ERP, Agile software
• Minitab software
• Previous experience in catheter manufacturing

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.

• Develop, modify , implement and maintain quality standards and protocols for the transformation of materials into finished or partially finished products.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and test mechanisms and equipment, conducts quality assurance tests and performs statistical analyses to evaluate the cost and determine the responsibility of products or materials that do not meet required standards and specifications.
• Leads and/or participates in corrective/preventive action teams to resolve production and customer issues. Ensures that corrective actions meet acceptable reliability standards and that documentation complies with requirements.
• May specialize in the areas of design, incoming materials, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.
• Perform or provide advice to Manufacturing Engineering on effective process validation, test method validation and investigation of non-conforming materials.
• Ensure that local quality records relating to finished devices, such as device reference records, device history records, reference validation plans, process Failure Modes, Effects and Criticality Analysis (FMECAs), etc. are accurate , up to date and compliant with regulations.
• Disposes of all materials/components rejected for non-conformance by thoroughly investigating causes and determining effective corrective actions.
• Identifies and implements continuous improvement ideas based on observations made during daily activities.Investigates and evaluates product problems in the field