Quality Engineer II

Medtronic • North Haven, CT

6d • Onsite

About The Position

The Quality Engineer II will support the Surgical Sutures’ Manufacturing business within Medtronic’s Surgical Innovations group located in North Haven, CT. This role is integral to ensuring the highest standards of quality and compliance in our medical device manufacturing processes. As a member of our Quality team, you will collaborate cross-functionally to enhance product reliability, optimize processes, and uphold regulatory compliance. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working 5 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary. This role is 100% onsite at our North Haven, CT manufacturing site.

Requirements

• 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.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Nice To Haves

• Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or related discipline); advanced degree preferred.
• Experience working in a 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.

Benefits

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)
• Incentive plans
• 401(k) plan plus employer contribution and match
• Short-term disability
• Paid time off
• Paid holidays
• Employee Stock Purchase Plan
• Employee Assistance Program
• Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
• Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level