Principal Quality Systems Specialist

Principal Quality Systems Specialist

Requirements

• Requires a Bachelor’s Degree
• Minimum of 7 years of medical device quality, regulatory or engineering experience
• Or an advanced degree with a minimum of 5 years of medical device quality, regulatory or engineering experience

Responsibilities

• Provides continuous and rigorous assessment of quality system, compliance, audit activities, processes, and documentation to assure compliance with Medtronic internal policies and quality system processes, FDA regulations, ISO 13485, Medical Device Requirements, and governmental regulations.
• Leads and assists in preparation for internal and external regulatory and notified body audits including FDA. Participates in internal and external audits and inspections in multiple audit support roles in the front and back room. Supports response owners with root cause, correction, corrective action, and effectiveness. Conducts internal audits and mock audits for SH&A entities and functions.
• Prepares Quality System compliance training materials and provides Quality System compliance training to entities and functions within the SH&A organization.
• Leads quality system projects. Participates in Quality System process activity across multiple sites including quality system projects and initiatives.
• Provides guidance, support and mentors quality process owners.Supports the development and implementation of Quality System procedures.
• Provide Quality System metrics and reporting on critical aspects regarding the health of the Quality System.
• Performs other related duties as assigned.

Preferred Qualifications

• Experience working in medical device, pharmaceutical and/or a comparable regulated environment
• Experience working with Quality Systems procedures and requirements
• Experience working with audit findings, corrections, and corrective actions
• Experience working with external standards and reviewing technical documentation
• Experience with quality tools and process improvement techniques
• Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
• Influence management skills; ability to work constructively across all functions of the organization as well as external customers
• Ability to educate people on Quality Systems, Audit, and CAPA programs
• Project management skills
• Strong written and verbal communication skills
• Strong analytical and decision-making skills
• Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements.