Laboratory Quality Engineer III

Additional Location(s): US-MN-Maple Grove; US-MN-Arden Hills

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.           

About the role:

Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.

The Preclinical Laboratory Quality Engineer provides quality support for Boston Scientific Preclinical testing laboratories, suppliers and studies worldwide to determine compliance with established internal and external requirements, including ISO 13485, 21 CFR 820, 21 CFR 58, ISO 10993 and ISO/IEC 17025, as applicable. This role evaluates quality system effectiveness, supports inspection readiness and contributes to the Preclinical Corrective and Preventive Action (CAPA) program.

This position serves as Quality Assurance or Quality Engineer, as applicable, for internal Boston Scientific procedures and preclinical laboratory studies, and conducts internal and external quality reviews to ensure compliance with regulatory requirements and company policies.

Work model, sponsorship, relocation:

This role is on-site and requires employees to work from the designated Boston Scientific location on a full-time basis. Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time. Relocation assistance is not available for this position at this time.

Your responsibilities will include:

• Support laboratory functions to maintain compliance with applicable regulations and standards, validated methods, and internal policies, procedures and work instructions, while promoting continuous inspection readiness.

• Collaborate with quality management and laboratory management on process improvement initiatives, quality trends and continuous improvement projects.

• Conduct internal and external quality assurance audits of systems, testing laboratories, procedures and controls used in testing activities under applicable regulations and standards.

• Plan, schedule and conduct vendor audits.

• Partner with global preclinical teams and Strategic Sourcing regarding new vendor requests and ongoing vendor needs.

• Evaluate the adequacy and compliance of systems, operations and practices through facility- and process-based audits and quality monitoring activities.

• Assess the accuracy, validity and overall quality of preclinical study data.

• Communicate final results of quality reviews and audits to management and technical staff.

• Write and publish audit and quality review reports, obtain appropriate approvals and distribute findings to responsible stakeholders.

• Oversee follow-up of corrections and corrective actions, escalate overdue items and support timely closure.

• Support or lead assigned quality projects and initiatives.

• Track audits and responses, support document review activities and maintain appropriate records.

• Contribute to the development and continuous improvement of quality procedures and processes.

• Assist laboratories in preparation for accrediting body, notified body, FDA or other regulatory inspections.

• Support the preclinical organization in meeting Boston Scientific Quality System requirements.

• Support the CAPA process in partnership with CAPA owners.

• Support compliance review meetings in accordance with site procedures.

Qualifications:

Required qualifications:

• Bachelor’s degree in chemistry or related life sciences discipline

• Strong technical and quality knowledge of ISO/IEC 17025, ISO 13485 and/or 21 CFR 58

• Strong verbal and written communication skills, both technical and conversational

• Minimum of 3 years' experience in a technical role

Preferred qualifications:

• Minimum of 2 years' experience working in a quality role

• Minimum of 5 years' experience working in the medical device industry or other similarly regulated industry, such as pharmaceuticals, biologics or preclinical environments

• Strong experience with 21 CFR 58 (GLP)

• Boston Scientific experience

Requisition ID: 625595 

Minimum Salary: $ 78300 

Maximum Salary: $ 148800 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com—will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.

Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions.  This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement.  The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.