Additional Location(s): N/A
About the RoleThe IO&E Divisional Quality Systems & Design Post-Market Surveillance Lead will serve as the divisional leader responsible for integrating Post-Market Surveillance, Quality Management Review (QMR), Quality Systems governance, and Guardian sustainability activities across the IO&E portfolio.
This role will ensure product performance data, complaint trends, risk management activities, quality system health, and management review processes are effectively connected to support proactive quality management, informed decision-making, and continuous improvement. The individual will partner closely with Design Assurance, Complaint Investigations & Trending, Data Analytics, Quality Systems, Regulatory Affairs, Medical Safety, and R&D to drive effective monitoring of product and quality system performance and support executive quality governance.
Work mode:At Boston Scientific, we value collaboration and synergy. This hybrid role is based in Maple Grove, MN or Arden Hills, MN and requires being on-site at least three (3) days per week.
Relocation assistance:Relocation assistance is not available for this position at this time.
Visa sponsorship:Boston Scientific will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.
Your Responsibilities Will IncludeQuality Management Review (QMR) & Quality Systems Governance- Support Arbor Lakes site-level QMR activities as the primary IO&E Quality representative, including coordination of divisional inputs and follow-through on assigned actions.
- Own the IO&E divisional QMR process, including development of Quality Management Reports, executive review materials, dashboards, and key quality metrics that provide a holistic view of product performance, quality system health, and Guardian sustainability.
- Lead integration of product performance, complaint, risk management, quality system health, and Guardian sustainability metrics into Quality Management Review processes and executive reporting to support proactive identification and management of quality risks.
- Partner with cross-functional teams to identify, escalate, and drive resolution of systemic quality and compliance risks.
- Monitor effectiveness of quality system improvements, support inspection readiness activities, and ensure management review actions are completed and sustained.
Design Post-Market Surveillance Leadership- Serve as the divisional Design PMS lead and subject matter expert, with Design Assurance accountability for PMS Plans, PSURs, post-market risk assessment, and integration of post-market information into product risk management.
- Partner with Complaint Investigation & Trending and Data Analytics as key providers of complaint data, trend analyses, and emerging signals; lead the Design Assurance evaluation of those inputs with Regulatory Affairs, Medical Safety, and R&D to determine required PSUR, risk management, design, or other product lifecycle actions.
- Drive growth and maturity of Design PMS practices by ensuring post-market learnings are systematically incorporated into Risk Management, Design Controls, CAPA activities, and continuous improvement throughout the product lifecycle, including Guardian-related surveillance and remediation activities.
- Provide training and guidance to Design Assurance team to drive consistent application of post-market surveillance processes and effective utilization of post-market data.
- Monitor the effectiveness of Design PMS integration across the division, identify capability gaps, and lead improvements that strengthen how Design Assurance understands and applies post-market information within PSUR and risk management processes.
What We're Looking For In YouRequired Qualifications- Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.
- Minimum of 8 years of experience in Medical Device Quality, Design Assurance, Post-Market Surveillance, Quality Systems, or a related regulated environment.
- Demonstrated ability to lead effectively across a broad set of cross-functional partners and diverse functions in a highly matrixed environment.
- Proven ability to apply systematic problem-solving methodologies to identify and resolve quality issues.
Preferred Qualifications- Experience with PMS Plans, PSURs, complaint analytics, product performance monitoring, and quality system governance.
- Experience supporting site or divisional Quality Management Review processes.
- Experience developing executive-level dashboards, metrics, and quality reporting.
- Strong understanding of Design Controls, Risk Management, and post-market regulatory requirements.
- Experience leading quality remediation, quality system transformation, or continuous improvement initiatives.
Requisition ID: 634306Minimum Salary: $ 102100 Maximum Salary: $ 194000 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).
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