Hybrid Senior Quality Systems Specialist – CR CMO

at Medtronic

• Job title: Senior Quality Systems Specialist – CR CMO
• Job type: Full Time
• Experience level: Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Alajuela, Costa Rica

About the role

• Quality Systems Specialist overseeing QMS activities for Medtronic, requiring extensive CAPA process and regulatory knowledge. Supporting compliance and quality management systems with Alajuela location.

Responsibilities

• 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.

Requirements

• Requires University Bachelor degree (engineering or equivalent).
• Minimum of 4 years of relevant experience about: CAPA process, Quality Management Systems (QMS), Change Control and Audit (internal and external).
• High level of knowledge about FDA Title 21 CFR Part 820 and ISO13485:2016.
• Proficient in Microsoft Excel: data analysis, trending, pivot tables for CAPA metrics.
• Fluent in English: written and spoken (supports USA Customer from Costa Rica).
• US Visa: business (B1) or tourist (B2), probability to travel.
• Demonstrated experience leading CAPA process and investigations, as owner or administrator.
• Experience facing auditors and defending processes as subject matter expert.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package.
• A commitment to our employees lives at the core of our values.
• Wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).