Quality Systems Lead: FDA/ISO Compliance & Audits

Medtronic plc; North Haven (CT); On-site; USD 75,000 - 113,000; Full time

Benefits offered by this job

Health, Dental and Vision Insurance

Health Savings Account

401(k) plan with match

Tuition assistance/reimbursement

Job summary

Medtronic plc seeks a Quality/Regulatory Compliance professional to own investigations, conduct root-cause analyses, and drive CAPAs within the global regulatory framework. You will provide quality system support to maintain FDA and ISO compliance across QMS programs, supporting EU units and manufacturing processes.

The role requires extensive knowledge of FDA and ISO standards, with experience leading audits and communicating findings to stakeholders.

Qualifications

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

Responsibilities

• Own and drive investigations, root cause analysis and CAPAs.
• Provide quality system support to maintain regulatory compliance (FDA and international).
• Lead internal and external audits per regulatory standards.
• Perform trend analyses and report compliance observations.
• Communicate business issues to management and drive corrective actions.

Skills

Regulatory knowledge

Quality systems

Education

Bachelor’s Degree

Job description

Medtronic plc seeks a Quality/Regulatory Compliance professional to own investigations, conduct root-cause analyses, and drive CAPAs within the global regulatory framework. You will provide quality system support to maintain FDA and ISO compliance across QMS programs, supporting EU units and manufacturing processes.

The role requires extensive knowledge of FDA and ISO standards, with experience leading audits and communicating findings to stakeholders.