Quality Engineer II

Medtronic•North Haven, CT

3d•$79,200 - $118,800•Onsite

About The Position

The Quality Engineer II supports the Surgical Sutures Manufacturing business within Medtronic’s Surgical Innovations group and Enterprise Operations. The Quality Engineering function supports medical device manufacturing operations through process validation, quality system execution, and maintenance of quality standards. This role provides quality engineering support for manufacturing operations, with a primary focus on process validation and quality system execution. The engineer partners with Engineering and Manufacturing to maintain product and process quality, execute validation activities, address nonconformances, and ensure required quality documentation is complete and compliant. The position is 100% onsite at Medtronic’s North Haven, Connecticut manufacturing site, five days per week.

Requirements

Bachelor’s degree in Engineering, Science, or a technical field with at least 2 years of Engineering and/or Quality experience, or an advanced degree in Engineering, Science, or a technical field with 0 years of Engineering and/or Quality experience.
For baccalaureate degrees earned outside of the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice To Haves

Bachelor’s degree in Chemical, Biomedical, or Mechanical Engineering; an advanced degree is preferred.
Manufacturing environment experience.
Process validation experience across the validation lifecycle, including Installation Qualification (IQ), Operational Qualification (OQ), Test Method Validation (TMV), and Performance Qualification (PQ).
Corrective and Preventive Action (CAPA) experience.
Experience with Minitab statistical software and/or Six Sigma training.

Responsibilities

Develop, apply, and maintain quality standards and protocols for manufacturing processes and products.
Execute process validation activities across the validation lifecycle, supporting compliant and reliable manufacturing processes.
Partner with Engineering and Manufacturing to establish and maintain quality standards and resolve product and process quality issues.
Develop and implement inspection, testing, and evaluation methods for products, materials, processes, and production equipment.
Perform quality assurance testing and statistical analysis to evaluate process and product performance.
Investigate nonconforming products or materials and support corrective and preventive action (CAPA) activities.
Ensure corrective measures meet reliability standards and associated quality documentation complies with requirements.
Support quality activities across production control, product evaluation, reliability, incoming materials, and process quality.

Benefits

Competitive salary and flexible benefits package.
Short-term incentive through the Medtronic Incentive Plan (MIP).
Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
Health Savings Account and Healthcare Flexible Spending Account for eligible regular employees working 20 or more hours per week.
Life insurance and long-term disability leave for eligible regular employees working 20 or more hours per week.
Dependent daycare spending account and tuition assistance or reimbursement for eligible regular employees working 20 or more hours per week.
Simple Steps global well-being program for eligible regular employees working 20 or more hours per week.
Incentive plans for all regular employees.
401(k) plan with employer contribution and match for all regular employees.
Short-term disability, paid time off, and paid holidays for all regular employees.
Employee Stock Purchase Plan for all regular employees.
Employee Assistance Program for all regular employees.
Non-qualified Retirement Plan Supplement, subject to IRS earning minimums, for all regular employees.
Capital Accumulation Plan, available to Vice Presidents and above or subject to IRS earning minimums.