Boston Scientific · 2 weeks ago
Senior Post-Market Complaint Handling Process Control Lead
US-MA-Marlborough
Full-time
Onsite
Senior Level, Lead/Staff
$83K/yr - $157K/yr
5+ years expBoston Scientific is a leader in medical science committed to solving significant challenges in healthcare. The Senior Post-Market Complaint Handling Process Control Lead is responsible for establishing and maintaining process controls and quality metrics for complaint handling, ensuring compliance with regulatory requirements and driving continuous improvement initiatives.
Health CareMedicalMedical Device
Responsibilities
Establish robust process controls for complaint handling process outputs that remain aligned with customer requirements
Collect, analyze, and report to senior management on key process outputs related to complaint handling
Utilize expertise in quality control, statistical methods, and systems thinking to drive continuous improvement initiatives for the complaint handling process
Lead and participate in root cause investigations for recurring process failures, implementing effective corrective and preventive actions (CAPAs)
Work closely with the complaint handling team, Risk Management, and IT/Systems
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
Lead a team of global and divisional subject matter experts responsible for the monitoring of the complaint handling process
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
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
Qualification
Required
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
Preferred
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, ISO13485 and ISO 14971
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
10001+ employees
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Leadership Team
Michael Mahoney
Chairman, President & CEO
Daniel J. Brennan
Chief Financial Officer
Recent News
BioWorld Financial Watch
2025-12-25
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2025-12-11
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