Sr Quality Systems Specialist.

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. A Day in the Life Sr CAPA Admin for Tempe Arizona | Remote Support (hybrid) ------------------------------------------------------------------------------------------------------ GENERAL (ESSENTIAL): • Fluent in English (C1-C2): written and spoken (supports USA Customer from Costa Rica). • US Visa: business (B1) or tourist (B2), probability to travel. • High level of knowledge about FDA Title 21 CFR Part 820 and ISO13485:2016 • Requires University Bachelor degree (engineering or equivalent). • Minimum of 4 years of relevant experience about CAPA process. • Work with minimum supervision: independent and autonomous professional. • Experience facing auditors and defending processes as subject matter expert. ------------------------------------------------------------------------------------------------------ SOFT SKILLS (ESSENTIAL): • Great customer service. • Emotional intelligence. • Capacity to influence entire organization. • Initiative and positive approach for collaborating with team and internal customers. • Proactive and innovative when solving problems and provide solutions. • Willing to teach and mentor others about CAPA knowledge. • Continuous improvement thinking. ------------------------------------------------------------------------------------------------------ CAPA KNOWLEDGE (ESSENTIAL): • This position will lead (remotely from Costa Rica) Site CAPA Board and CAPA Process improvement for current Medtronic Internal Customer located at USA. • Demonstrated experience leading CAPA process and investigations, as owner or administrator. • High level of expertise and knowledge about CAPA, problem solving (DMAIC, root cause analysis, effectiveness), story telling and basic statistics. • Proficient in Microsoft Excel: data analysis, trending, pivot tables for CAPA metrics. • Experienced about Section 820.100 and "Continuous improvement (ISO13485:2016)" Responsibilities may include the following and other duties may be assigned. Provides 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. Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance. Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations. Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external. Co-ordinates legal requests in support of government investigations or litigations. Ensures the quality assurance programs and policies are maintained and modified regularly. Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally. SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects – from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: ... (truncated, view full listing at source)