Operations Quality Engineer II

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

Benefits offered by this job

Health, Dental and Vision Insurance

Tuition reimbursement

401(k) with employer match

Paid time off

Job summary

Medtronic in North Haven, CT is seeking an Operations Quality Engineer II to lead quality initiatives in manufacturing, drive process improvements, and ensure compliance across production operations.

You will partner with engineering, manufacturing and quality teams to implement inspection, validation, CAPA, and data analysis strategies, aiming for product reliability and operational excellence. Onsite role, five days a week, with limited travel.

Qualifications

• Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience.
• Experience with CAPA, quality systems, and regulatory compliance.
• Experience with process and product data analysis using statistical tools.

Responsibilities

• Support quality engineering initiatives to improve product quality and manufacturing performance.
• Partner with manufacturing and engineering to establish and enhance quality standards.
• Develop and implement inspection, testing, validation, and monitoring strategies.
• Analyze quality data to identify trends, investigate issues, and drive corrective actions.
• Lead root cause investigations and verify effectiveness of CAPA.
• Support audit readiness and compliant documentation.

Skills

Root cause investigations

CAPA implementation

Statistical analysis

Lean Six Sigma

Cross-functional collaboration

Education

Bachelor's degree in quality/manufacturing/engineering

Master's degree (optional)

Tools

Quality Systems (QSR/ISO 13485)

CAPA processes

Job description

We anticipate the application window for this opening will close on - 12 Nov 2026

Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.

A Day in the Life

This role supports the Operations Quality function within Advanced Surgical Instruments (ASI), specifically supporting the Stapling product families in a manufacturing environment focused on ensuring product quality, process performance, and compliance across production operations. The team partners closely with Engineering, Manufacturing, and cross-functional stakeholders to develop and maintain quality systems, resolve complex quality issues, and drive continuous improvement initiatives that support product reliability and operational excellence.

This position is based in North Haven, Connecticut and requires onsite presence five (5) days per week. Minimal travel is expected.

As an Operations Quality Engineer II, you will serve as a quality leader supporting manufacturing operations, engineering initiatives, and quality system improvements. This role is responsible for driving product and process quality, leading complex investigations and improvement projects, and partnering cross-functionally to ensure compliance, operational excellence, and product reliability.

Primary Responsibilities

• Support quality engineering initiatives that improve product quality, manufacturing performance, and quality system effectiveness.
• Partner with manufacturing and engineering teams to establish, maintain, and enhance quality standards and control methods.
• Develop and implement inspection, testing, validation, and monitoring strategies for products and production processes.
• Analyze quality, process, and production data to identify trends, investigate issues, and drive corrective and preventive actions.
• Execute root cause investigations and ensure effective implementation and verification of corrective actions.
• Support regulatory, internal, and external audit readiness through compliant documentation and quality system execution.

Required Qualifications

• Bachelor's degree with 2+ years of quality, manufacturing, or engineering experience OR Master's degree with 0 years of quality, manufacturing, or engineering experience.

Preferred Qualifications

• Experience in medical device, pharmaceutical, biotechnology, or other highly regulated manufacturing environments, including supporting quality systems.
• Knowledge of Quality System Regulation (QSR), ISO 13485, or other applicable quality standards.
• Experience with process validation, test method validation, and/or equipment qualification activities.
• Experience conducting root cause investigations, implementing corrective and preventive actions (CAPA), and analyzing quality/process data using statistical and problem-solving tools.
• Experience supporting continuous improvement initiatives using Lean, Six Sigma, or similar methodologies; related certifications such as ASQ Certified Quality Engineer (CQE) or Six Sigma preferred.
• Experience collaborating with cross-functional manufacturing, engineering, quality, and operations teams.

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

U.S. Work Authorization & Sponsorship

At Medtronic, we are committed to fostering an environment where employees can thrive and make a meaningful impact. In alignment with our enterprise-wide workforce planning approach, U.S. work authorization sponsorship (H-1B, TN, J, etc.) is offered exclusively for Principal-level roles and above, where specialized expertise aligns with long-term business needs. Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.

Recruitment Fraud Alert

Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic.com email addresses.

Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.

If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments.

If you have any questions, concerns regarding the authenticity of a communication alleged to have been made by or on behalf of Medtronic, please contact us immediately at [e-mail].

Benefits & Compensation

Medtronic offers a competitive Salary and flexible Benefits Package. A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.

Salary ranges for U.S (excl. PR) locations (USD):$79,200.00 - $118,800.00

This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns. Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

If you are applying to perform work for Medtronic, Inc. (“Medtronic”) in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Medtronic will consider for employment qualified job applicants with arrest or conviction records in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.