Quality Systems Lead — Regulatory Compliance & Audits

BioCT Innovation Commons; North Haven (CT); On-site; USD 90,000 - 125,000; Full time

Job summary

Medtronic in North Haven, CT is seeking a Quality/Regulatory professional to drive investigations, root cause analyses, and corrective actions for finished medical devices. You will support the quality system, ensure regulatory compliance, and coordinate audits across the organization.

The role requires knowledge of FDA requirements, ISO 13485, QSR, MDSAP, and HIPAA, plus 4+ years of relevant experience. Expect travel about 25% and collaboration with multiple teams to advance patient safety and

Qualifications

• Bachelor’s Degree required.
• Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• Knowledge of FDA, GMP, QSR and ISO 13485, and MDSAP for finished medical devices.

Responsibilities

• Own and drive investigations, root cause analysis and corrective and preventive actions.
• Provide quality system support and guidance to maintain compliance with all FDA and international regulatory requirements.
• Provide oversight for the development and maintenance of quality systems, programs, processes, and procedures to ensure ongoing compliance with policies and global regulatory requirements.
• Support EU Surgical Operating Unit entities from a Quality Oversight perspective including setup of QMS processes, audits and certifications; reactive support for production quality issue resolution, PHO and FCA.
• Partner with and influence internal and external stakeholders to drive needed change and the execution of compliance program.
• Communicate business-related issues or opportunities to next management level.
• Lead, coordination and/or preparation of internal and external audits in accordance with regulatory standards (FDA and equivalents outside the US as well as other authorities).
• Perform trend analyses and report compliance observations to identify areas for improvement.
• Investigate and resolve compliance problems, questions, or complaints from other units, customers, regulators, etc.
• Master knowledge of applicable Quality, FDA medical device directives/regulations, HIPAA and ISO requirements and update policies accordingly.
• Maintain excellent writing and editing skills and computer proficiency.
• Travel within US and internationally approximately 25%.

Skills

Writing skills

Computer skills

Education

Bachelor’s degree

Job description

Medtronic in North Haven, CT is seeking a Quality/Regulatory professional to drive investigations, root cause analyses, and corrective actions for finished medical devices. You will support the quality system, ensure regulatory compliance, and coordinate audits across the organization.

The role requires knowledge of FDA requirements, ISO 13485, QSR, MDSAP, and HIPAA, plus 4+ years of relevant experience. Expect travel about 25% and collaboration with multiple teams to advance patient safety and