Onsite Quality Engineer II – Medical Devices

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

Benefits offered by this job

Health, Dental and vision insurance

401(k) plan with employer contribution

Tuition assistance/reimbursement

Job summary

Medtronic in North Haven, CT is seeking a Quality Engineer II to support the Surgical Sutures’ Manufacturing group. You will develop, maintain quality standards and collaborate with engineering and manufacturing to ensure compliance and reliability in medical device production.

The role is 100% onsite, five days a week, with opportunities to drive CAPA, process validation and continuous improvement across IQ, OQ, TMV, and PQ lifecycles.

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.
• Experience in fast-paced Manufacturing environment.
• Good communication skills, written and verbal.
• Work experience in process validation across the full validation lifecycle also IQ, OQ, TMV, PQ.
• CAPA (Corrective Action / Preventive Action) experience.
• Familiarity with Minitab Statistical Software.
• Six Sigma Training.

Responsibilities

• Develop, modify, apply and maintain quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborate with engineering and manufacturing functions to ensure quality standards are in place.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; and perform statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensure that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality.

Skills

Quality standards

Statistical analysis

CAPA experience

Minitab

Six Sigma

Education

Bachelor’s degree in Engineering/Science/Technical field

Advanced degree in Engineering/Science or 2+ years experience

PhD with 0 years relevant experience

Tools

IQ

OQ

TMV

PQ

Job description

Medtronic in North Haven, CT is seeking a Quality Engineer II to support the Surgical Sutures’ Manufacturing group. You will develop, maintain quality standards and collaborate with engineering and manufacturing to ensure compliance and reliability in medical device production.

The role is 100% onsite, five days a week, with opportunities to drive CAPA, process validation and continuous improvement across IQ, OQ, TMV, and PQ lifecycles.