Quality Engineer II - Medical Devices, Onsite

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

Benefits offered by this job

Health insurance

Dental and vision insurance

HSA

Tuition assistance

401(k) match

Paid time off

Paid holidays

Employee Stock Purchase Plan

Employee Assistance Program

Well-being program

Job summary

Medtronic is seeking a Quality Engineer II to support Surgical Sutures Manufacturing in North Haven, CT. You will develop quality protocols, collaborate with engineering and manufacturing, and perform QA testing with statistical analysis to ensure regulatory compliance.

The role requires a engineering/science degree with 2–4+ years in quality, plus experience in process validation (IQ/OQ/PQ) and CAPA; Six Sigma training is preferred. On-site work five days a week at the North Haven site.

Qualifications

• Bachelor’s degree in Engineering, Science or technical field with 4+ years of work experience in Engineering and/or Quality OR Advanced degree in Engineering, Science or technical field with 2+ years of work experience in Engineering and/or Quality OR PhD with 0 years relevant experience.
• Preferred: Engineering degree in Chemical, Biomedical, Mechanical or related discipline.
• Experience in fast-paced Manufacturing environments; CAPA, IQ/OQ/PQ familiarity; Six Sigma training.

Responsibilities

• Develop, modify, apply and maintain quality standards and protocol for processing materials into finished products.
• Collaborate with engineering and manufacturing to ensure quality standards are in place.
• Design inspection/testing mechanisms; conduct QA tests; perform statistical analysis.
• Ensure corrective actions meet reliability standards and documentation is compliant.
• May specialize in design, incoming material, production control, product evaluation and reliability.

Skills

Communication skills

Process validation

CAPA

Six Sigma

Education

Bachelor’s degree in Engineering/Science or technical field

Advanced degree in Engineering/Science

PhD

Tools

Minitab

Job description

Medtronic is seeking a Quality Engineer II to support Surgical Sutures Manufacturing in North Haven, CT. You will develop quality protocols, collaborate with engineering and manufacturing, and perform QA testing with statistical analysis to ensure regulatory compliance.

The role requires a engineering/science degree with 2–4+ years in quality, plus experience in process validation (IQ/OQ/PQ) and CAPA; Six Sigma training is preferred. On-site work five days a week at the North Haven site.