About the position
At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. In this exciting role as a Principal Quality Systems Specialist, you will manage assigned projects and work with other stakeholders to achieve desired results within the quality systems. The Cranial and Spinal Technologies Organization (CST) develops life-restoring therapies and healthcare solutions that span the care continuum, integrating technologies and applying clinical and economic evidence to increase patient access, improve the efficiency of procedures, and deliver successful patient outcomes. Within CST, this role will support Spine & Biologics, which offers procedural solutions for spine surgery and bone grafting solutions for spinal fusion. In this position, you will provide oversight for developing and maintaining 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. You will also provide expertise and guidance in interpreting policies, regulatory and governmental regulations, and internal regulations to assure compliance. Additionally, you will work directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet regulations. Your responsibilities will include leading audit and inspection preparation, resolving audit and inspection findings, and liaising with auditing groups and inspectors through all stages of the audits. You will prepare reports and necessary documentation, such as corrective and preventative actions, and provide them to applicable stakeholders, both internal and external. Furthermore, you will coordinate legal requests in support of government investigations or litigations, ensuring that quality assurance programs and policies are maintained and modified regularly. You will facilitate uniform standards worldwide and enable best practice sharing, thereby fostering the achievement of the company's mission globally. Ensuring QMS requirements and processes are established and maintained, conducting management reviews, and reporting QMS performance and effectiveness, including any need for improvement, to Management with Executive Responsibility will also be part of your role. Lastly, you will promote awareness of applicable regulatory, customer, and QMS requirements throughout the organization.
Responsibilities
- Provides oversight for developing and maintaining 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 governmental regulations, and internal regulations to assure compliance.
- Works directly with operating entities to provide process analysis oversight, continuing to enforce requirements and meet regulations.
- Leads audit and inspection preparation, resolves audit and inspection findings, and liaises with auditing groups and inspectors through all stages of the audits.
- Prepares reports and necessary documentation (e.g., corrective and preventative actions) and provides them to applicable stakeholders, both internal and external.
- Coordinates 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 the company's mission globally.
- Ensures QMS requirements and processes are established and maintained.
- Conducts management reviews and reports QMS performance and effectiveness, including any need for improvement, to Management with Executive Responsibility.
- Ensures the promotion of awareness of applicable regulatory, customer, and QMS requirements throughout their organization.
Requirements
- Bachelor's degree required.
- Minimum of 7 years of quality systems experience or advanced degree with a minimum of 5 years experience.
Nice-to-haves
- HCT/Ps are subject to the regulations in 21 CFR 1271, including establishment registration, donor eligibility (donor screening and testing), Current Good Tissue Practice (CGTP), additional regulatory requirements.
- Audit - Quality and Compliance Experience
- Corrective and Preventative Action (CAPA)
- Quality Management System Experience
- AAMI - The Quality System Regulation 21 CFR 820 and ANSI/AAMI/ISO 13485
- AATB Accreditation Experience
- Think Reliability - Cause Mapping
- Lean Sigma Trainings
Benefits
- Competitive Salary
- Flexible Benefits Package
- Short-term incentive called the Medtronic Incentive Plan (MIP)
