Senior Quality Systems Engineer - Bolt Integration

The Senior Quality Systems Engineer supports the Bolt Medical Acquisition Integration team. This role provides global process and quality system support, partnering with cross-functional stakeholders to maintain compliance, drive continuous improvement and ensure effective quality system integration and performance. The position contributes to the development, enhancement and integration of quality system processes and tools that support compliant product and information lifecycle management across the SEISMIQ product platforms and supporting sites.

Work mode:

This role follows a hybrid work model requiring employees to be in one of our local offices in MN, primarily Arbor Lakes or Arden Hills, MN at least three days per week., Integration Support

• Support integration of legacy processes and products into the BSC quality system.
• Own and drive deliverables associated to integration execution in alignment with the global quality systems roadmap and overall program priorities.
• Participate in and lead Communities of Practice activities to promote standardization and adoption of best practices.
• Lead or support continuous improvement initiatives using structured methodologies to drive efficiency, scalability and operational excellence.
• Identify, analyze and resolve quality system issues using systematic problem-solving methodologies.

Audit and Compliance

• Support standardization efforts and maintain audit readiness in accordance with applicable regulations and standards, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Support external audits and regulatory inspections through preparation, execution, back-room support and follow-up activities.
• Develop training materials, audit support documentation and related compliance resources.
• Serve as an audit-facing subject matter expert for assigned quality processes and digital quality systems.
• Ensure compliance to external standards and regulations through the integration process, including maintenance of supporting documentation.

Nonconformance & CAPA

• Serve as an owner or lead contributor for nonconformance, exception and CAPA activities.
• Serve as CAPA mentor.
• Contribute to risk management activities and systemic issue resolution efforts.

• Bachelor's degree in Engineering, quality, life sciences or a related field
• 5 years' experience in quality systems within a regulated industry
• Working knowledge of regulations and standards applicable to the Boston Scientific Global Quality System and Document and Records Control processes, including ISO 13485, 21 CFR Part 820 and EU MDR.
• Demonstrated experience partnering with cross-functional stakeholders to support quality system processes
• Ability to travel up to 25%

Preferred qualifications

• Proven experience supporting audits and inspections
• Prior experience with CAPA activities
• Integration experience
• Proven ability to influence without authority

3.93.9 out of 5 stars Arden Hills, MN Hybrid work $85,000 - $161,500 a year, 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.   You must create an Indeed account before continuing to the company website to apply