Quality Engineer II — Medical Device CAPA & Validation

medtronic; Connecticut; On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health Insurance

401(k) plan

Paid time off

Employee stock purchase plan

Tuition assistance

Job summary

Medtronic in Mystic, CT is seeking a Quality Engineer II to support quality system activities in a regulated medical device environment, focusing on nonconformance investigations, CAPA, calibration, process and equipment validation, and regulatory compliance.

You will collaborate across manufacturing, engineering, and operations to maintain quality system effectiveness, support manufacturing operations, and drive continuous improvement initiatives.

Qualifications

• Requires a Baccalaureate degree and minimum of 2 years of relevant experience OR Master's degree with a minimum of 0 years relevant experience.
• Experience supporting quality system processes within a regulated manufacturing environment.
• Experience with nonconformance investigations, root cause analysis, and corrective action implementation.
• Working knowledge of quality documentation requirements and regulatory compliance standards.
• Ability to manage multiple projects and priorities while maintaining accurate and compliant documentation.

Responsibilities

• Support nonconformance investigations and partner with cross-functional teams to identify root causes and implement corrective actions.
• Facilitate Corrective and Preventive Action (CAPA) activities, including documentation, effectiveness verification, and closure.
• Maintain compliance of calibration programs and support calibration-related quality activities.
• Execute and support process and equipment validation activities, including IQ, OQ, PQ, and related validation documentation.
• Collaborate with manufacturing and engineering teams to establish, implement, and maintain product and process quality requirements.
• Develop, revise, and maintain quality documentation, procedures, and records to ensure compliance with quality system requirements.
• Analyze quality data and trends to identify improvement opportunities and support risk-based decision-making.
• Participate in internal audits, inspections, and regulatory readiness activities to ensure ongoing compliance.

Job description

Medtronic in Mystic, CT is seeking a Quality Engineer II to support quality system activities in a regulated medical device environment, focusing on nonconformance investigations, CAPA, calibration, process and equipment validation, and regulatory compliance.

You will collaborate across manufacturing, engineering, and operations to maintain quality system effectiveness, support manufacturing operations, and drive continuous improvement initiatives.