Quality Eng II

Additional Location(s): N/ADiversity – 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.

This role leads technical efforts at the Arden Hills Post Market Complaint Investigation Site (CIS), focusing on analyzing product performance data to investigate and escape? Replace? ...

At Boston Scientific, we value collaboration and synergy. This role follows an onsite work model, requiring employees to be in our local office at five days per week.

Relocation assistance is not available for this position at this time.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

• Analyze post-market surveillance data, including customer complaints and adverse events, to ensure timely identification, investigation, and resolution of safety or quality issues in compliance with regulatory and internal standards.
• Lead product signal escalations by conducting root cause investigations, documenting findings in the quality system, and identifying opportunities for performance improvement. May include ownership of NCEPs and CAPAs.
• Collaborate cross-functionally to develop and implement efficient, compliant solutions that enhance Complaint Investigation Site (CIS) processes and support organizational and regulatory goals.
• Communicate product performance insights through formal presentations to leadership and design teams, support published performance reports, and respond to customer inquiries directly or via the sales organization.
• Uphold a strong commitment to patient safety and product quality by ensuring adherence to the Quality Policy and all relevant procedures and standards.

• 2 years of experience with a Bachelor’s degree in engineering or other related technical/scientific discipline

• Knowledgeable in Quality System Regulations, Medical Device Regulation, and ISO 13485 Quality Standards
• Experience in Medical Device industry or a Quality organization
• Proficient with Microsoft Office tools including Word, Excel, PowerPoint, and Outlook
• Ability to collaborate and influence across multiple, cross-functional teams
• Knowledge of analytical techniques, problem solving, continuous improvement programs, and statistical analysis
• Self-starter with the ability to identify improvement opportunities

Minimum Salary: $69500

Maximum Salary: $132000

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see 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.

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