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.

REQUIRED KNOWLEDGE AND EXPERIENCE:

• Bachelor’s degree
• Three years of work experience in quality role, regulatory affairs within pharma or medical devices industry
• Fluent in English
• Expertise in CAPA compliance & investigation techniques
• Knowledge with ISO 9001: 2015 and ISO 13485:2016
• Knowledge with Power BI and Auditing experience is advantageous.

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.

• Provide oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines
• Provide expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance
• Work directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations
• Lead audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits
• Prepare reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external
• Co-ordinate legal requests in support of government investigations or litigations
• Ensure the quality assurance programs and policies are maintained and modified regularly
• Facilitate uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company’s mission globally