Quality Engineer II
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 manufacturing operations through process validation, quality system execution, and maintenance of quality standards for medical device manufacturing. This position is 100% onsite at the North Haven, Connecticut manufacturing site, five days per week. The role provides quality engineering support for manufacturing operations, with a primary focus on process validation and quality system execution. The Quality 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.
Requirements
- Bachelor’s degree in Engineering, Science, or a technical field and 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 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 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
- Health insurance
- Dental insurance
- Vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Global well-being program
- Incentive plans
- 401(k) plan with 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
- Short-term incentive through the Medtronic Incentive Plan (MIP)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
