Quality Engineer II — Medical Devices (Process Validation, Onsite)

Medtronic plc; North Haven (CT); On-site; USD 79,000 - 119,000; Full time

Benefits offered by this job

Health insurance

401(k) plan plus employer match

Employee Stock Purchase Plan

Job summary

Medtronic plc in North Haven, CT seeks a Quality Engineer II to support Surgical Sutures Manufacturing within the Surgical Innovations group. The role focuses on process validation, quality systems, CAPA, and collaboration with Engineering and Manufacturing to ensure compliant, high-quality products.

On-site five days a week, strong analytical skills and knowledge of IQ/OQ/TMV/PQ are required. The ideal candidate holds a Bachelor’s in Engineering/Science with 2+ years of quality experience; Six

Qualifications

• Bachelor’s degree in Engineering, Science, or a technical field required or advanced degree.
• 2+ years of Engineering/Quality experience preferred; US work authorization standard.
• Experience with process validation: IQ/OQ/TMV/PQ and CAPA activities.

Responsibilities

• Develop and maintain quality standards for manufacturing processes and products.
• Execute process validation activities across the validation lifecycle.
• Partner with Engineering and Manufacturing to maintain quality standards and resolve issues.
• Develop and implement inspection, testing, and evaluation methods for products and equipment.
• Perform QA testing and statistical analysis to evaluate process and product performance.
• Investigate nonconforming products and support CAPA activities.

Skills

Process validation

Quality systems

CAPA

Statistical analysis

Validation lifecycle

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Science, or a technical field

Advanced degree preferred

Tools

Minitab

Six Sigma

Job description

Medtronic plc in North Haven, CT seeks a Quality Engineer II to support Surgical Sutures Manufacturing within the Surgical Innovations group. The role focuses on process validation, quality systems, CAPA, and collaboration with Engineering and Manufacturing to ensure compliant, high-quality products.

On-site five days a week, strong analytical skills and knowledge of IQ/OQ/TMV/PQ are required. The ideal candidate holds a Bachelor’s in Engineering/Science with 2+ years of quality experience; Six