Quality Systems Associate Jobs in Minnesota (NOW HIRING)

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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 by Forbes as one of the Best Workplaces for Engineers in 2026, reflecting a culture where engineers do meaningful work.

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 Packaging, Sterilization and Men's Health team within Arden Hills Operations is seeking a Senior Quality Engineer to develop, implement and maintain quality engineering systems, methodologies and practices that ensure compliance with Boston Scientific, customer and regulatory requirements.

As a key quality representative, you will provide technical leadership and partner across functions to drive quality initiatives that support operational excellence, product quality and business objectives. You will play a critical role in process validation, risk management, process controls and continuous improvement efforts, ensuring products consistently meet internal and external requirements throughout the product life cycle. Working in a collaborative environment, you will lead quality engineering projects, mentor technical team members and apply data-driven problem-solving approaches to identify, resolve and prevent quality issues while strengthening manufacturing processes and quality system effectiveness.

Work model, sponsorship, relocation:

At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model requiring employees to work from our Arden Hills, Minnesota, location. 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:

• Select appropriate techniques for problem-solving and make sound, consistent engineering and quality assurance recommendations.
• Read and interpret technical drawings, procedures and protocols.
• Exercise independent authority to make decisions related to product quality, including the disposition of nonconforming product.
• Identify manufacturing process defects, including scrap, nonconforming material and customer complaints, by dispositioning nonconforming material, assisting with root cause identification and supporting corrective and preventive actions. Partner with process owners to define product holds and document release criteria as needed.
• Participate in customer complaint investigations for assigned manufacturing areas.
• Support the execution and investigation of corrective and preventive actions (CAPAs), nonconforming events, failure mode investigations and related quality system activities.
• Demonstrate and promote the highest standards of quality engineering discipline and technical rigor.
• Serve as a quality systems resource by promoting compliance with Quality System Regulation (QSR), ISO standards and applicable medical device regulations while escalating critical quality decisions to Quality Engineering leadership when appropriate.
• Apply advanced validation engineering expertise while ensuring compliance with applicable regulatory requirements.
• Review and approve operational, test and validation data to establish technical specifications and performance standards for new or modified products and processes.
• Champion continuous improvement and innovation from a quality perspective throughout the product life cycle, from supplier qualification through customer satisfaction.
• Provide technical guidance and mentorship to Quality Engineers, Associate Quality Engineers, technicians and inspection personnel.
• Partner with Environmental Health and Safety to identify significant environmental impacts and support goals and objectives that improve environmental performance.
• Collaborate with suppliers, manufacturing, engineering and cross-functional partners to resolve quality issues and drive operational excellence.
• Support internal quality audits and maintain audit readiness.

Qualifications:

Required qualifications:

• Bachelor's degree or higher, preferably in an engineering discipline.
• Minimum of 9 years' experience in operations quality.
• Strong understanding of quality operations fundamentals, regulatory requirements and quality systems.
• Experience working in regulated manufacturing environments.
• Experience with product risk assessment.
• Experience performing root cause analysis and implementing corrective and preventive actions.
• Experience with CAPA, nonconforming event and failure mode investigations.
• Experience with validation engineering and process validation.
• Knowledge of Quality System Regulation (QSR), ISO standards and medical device regulations.
• Experience reviewing operational, test and validation data to establish technical specifications and performance standards.
• Strong analytical and decision-making skills with the ability to solve complex quality issues.
• Excellent communication and cross-functional collaboration skills.
• Experience conducting customer complaint investigations.

Preferred qualifications:

• Experience in the medical device industry.
• Experience using data analysis to identify trends, determine root causes and implement effective solutions.
• Demonstrated ability to influence stakeholders and lead quality initiatives across cross-functional teams.
• Experience mentoring technical team members and providing engineering guidance.

Requisition ID: 631913 

Minimum Salary: $ 85000 

Maximum Salary: $ 161500 

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.