Senior Post-Market Complaint Handling Process Control Lead

Senior Post-Market Complaint Handling Process Control Lead

Join to apply for the Senior Post-Market Complaint Handling Process Control Lead role at Boston Scientific
.

About The Role

The Quality Engineer in Post-Market Complaints is responsible for establishing and maintaining the process controls and quality metrics used to monitor the accuracy and integrity of the outputs from the complaint handling process. This role is critical for ensuring compliance with regulatory requirements, including those from the FDA and other global regulatory bodies, and for maintaining processes that are efficient and stable.

• Process monitoring and control:
  Establish robust process controls for complaint handling process outputs that remain aligned with customer requirements.
• Data analysis and trending:
  Collect, analyze, and report to senior management on key process outputs related to complaint handling.
• Process improvement:
  Utilize expertise in quality control, statistical methods, and systems thinking to drive continuous improvement initiatives for the complaint handling process.
• Root cause analysis:
  Lead and participate in root cause investigations for recurring process failures, implementing effective corrective and preventive actions (CAPAs).
• Cross-functional collaboration:
  
  Work closely with the complaint handling team, Risk Management, and IT/Systems.
• Systems thinking and analysis:
  Evaluate the end-to-end complaint handling process, from intake to adverse event reporting, identifying and analyzing system-wide dependencies, bottlenecks, and potential failure modes to proactively mitigate risks.
• Technical Leadership:
  Lead a team of global and divisional subject matter experts responsible for the monitoring of the complaint handling process.
• Documentation and Standardization:
  Coordinate with global and divisional teams to create and maintain clear documentation, including Standard Operating Procedures (SOPs), work instructions, and control plans, to ensure consistency and compliance with medical device regulatory requirements.
• Define and establish process requirements based on customer needs:
  Take process outputs, such as complaint codes, and build process requirements that meet the needs of all downstream customers that use the outputs for analysis and decision making.

• Bachelor's degree in Industrial Engineering, Statistics, or a related technical discipline.
• 5+ years of experience in a quality control related role within a regulated industry, preferably medical devices or pharma.
• Experience with statistical process control (SPC) and other statistical tools for quality data analysis, with emphasis on SPC for business processes.

• ASQ Certified Quality Engineer (CQE), Lean Six Sigma or similar certification.
• Familiarity with systems thinking principles and the ability to apply them to complex business processes.
• Working knowledge of relevant medical device regulations, such as euMDR, ISO
  13485 and ISO 14971.

• Exceptional attention to detail and a methodical approach to data analysis.
• Strong analytical, problem-solving, and critical thinking skills.
• Excellent written and verbal communication skills, including the ability to present complex data to diverse audiences.
• Demonstrated ability to collaborate effectively with cross-functional teams.
• Proactive and accountable mindset with a focus on delivering solutions.

Requisition : 620797

Salary Information
:
Minimum Salary: $82,600;
Maximum Salary: $156,900. Compensation will be commensurate with experience and location. The statement above is intended for informational purposes and may vary by location and other factors.

Boston Scientific is an equal opportunity employer. We are committed to building a diverse and inclusive workforce. We do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other protected status.