Senior Quality Engineer

Medtronic; Boston (MA); In loco; USD 98.000 - 148.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental and vision insurance

401(k) plan

Employee Stock Purchase Plan

Descrizione del lavoro

Medtronic in Boxborough, MA is seeking a Senior Quality Engineer to support manufacturing operations, drive process improvements, and ensure regulatory compliance throughout the product lifecycle. The role collaborates across Quality, Manufacturing, Operations, R&D, and Regulatory Affairs and is onsite with no travel.

You will lead quality initiatives, analyze data, investigate issues, and develop documentation and validation protocols while ensuring QMS compliance and risk management practices

Competenze

• Bachelor’s degree and 4+ years of quality engineering, manufacturing, or regulated industry experience, or an advanced degree with 2+ years of quality engineering, manufacturing, or regulated industry experience.
• Experience applying quality tools for root cause analysis, corrective actions, and process improvement.
• Experience supporting quality systems within a regulated environment.
• Experience analyzing quality data and developing effective quality solutions.
• Working knowledge of process validation, risk management, or quality engineering methodologies.

Mansioni

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances.
• Support root cause investigations and resolution of product, process, and supplier quality issues.
• Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes.
• Ensure compliance with applicable Quality Management System requirements and regulatory standards.
• Participate in risk management activities and support product and process risk assessments.
• Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.

Conoscenze

Quality engineering

Root cause analysis

Process improvement

Quality systems

Quality data analysis

Process validation

Risk management

Quality engineering methodologies

Formazione

Bachelor's degree

Advanced degree

Descrizione del lavoro

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

Cranial & Spinal Technologies (CST) develops therapies, technologies, and procedural solutions for the treatment of disorders and injuries affecting the spine and cranial anatomy. The operating unit partners with healthcare providers worldwide to advance surgical outcomes through innovative implants, navigation, imaging, enabling technologies, and procedural excellence.

Check us out on LinkedIn: Medtronic CST

This position is based in Boxborough, Massachusetts, and supports onsite collaboration with cross-functional teams across Quality, Manufacturing, Operations, Research and Development, and Regulatory Affairs. This is an onsite role with no travel required.

The Senior Quality Engineer serves as a quality representative supporting manufacturing operations, process improvements, product quality initiatives, and regulatory compliance activities. This role partners across functions to drive product quality, ensure process effectiveness, investigate quality issues, and support continuous improvement efforts throughout the product lifecycle.

Primary Responsibilities

• Lead quality engineering activities supporting manufacturing processes and product quality performance.
• Partner with Manufacturing, Operations, and Research and Development teams to implement process improvements and quality controls.
• Analyze quality data, identify trends, and drive corrective and preventive actions to address nonconformances.
• Support root cause investigations and resolution of product, process, and supplier quality issues.
• Develop, review, and approve quality documentation, procedures, validation protocols, and engineering changes.
• Ensure compliance with applicable Quality Management System requirements and regulatory standards.
• Participate in risk management activities and support product and process risk assessments.
• Drive continuous improvement initiatives that enhance product quality, process capability, and operational performance.

Required Qualifications

• Bachelor’s degree and 4+ years of quality engineering, manufacturing, or regulated industry experience OR an advanced degree and 2+ years of quality engineering, manufacturing, or regulated industry experience.
• Experience applying quality tools for root cause analysis, corrective actions, and process improvement.
• Experience supporting quality systems within a regulated environment.
• Experience analyzing quality data and developing effective quality solutions.
• Working knowledge of process validation, risk management, or quality engineering methodologies.

Preferred Qualifications

• Experience in medical device manufacturing.
• Knowledge of United States Food and Drug Administration regulations, ISO 13485, and Quality System requirements.
• Experience with nonconformance, corrective and preventive action, and change control processes.
• Experience supporting product transfers, process validations, or manufacturing process improvements.
• Certification as a Quality Engineer or related quality certification through the American Society for Quality.

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.

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):$98,400.00 - $147,600.00

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).

• 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
• andSimple 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)
• andCapital 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.