Senior Post-Market Complaint Handling Process Control Lead
2 weeks ago
Senior Post-Market Complaint Handling Process Control Lead Recruiter: Spencer Gregory Hale Location: Arden Hills, MN, 55112 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. Key responsibilities include: 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 SOPs, work instructions, and control plans. 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. What we're looking for in you: 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 qualifications: 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. Core competencies: 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. Demonstrated ability to collaborate effectively with cross-functional teams. Proactive and accountable mindset with a focus on delivering solutions. Salary Range: $82,600 – $156,900 Equal Employment Opportunity Statement: Boston Scientific Corporation is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identity, veteran status, age, or disability. #J-18808-Ljbffr
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Arden Hills, United States Boston Scientific Full timeSenior 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...
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Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory Hale Senior Post-Market Complaint Handling Process Control Lead 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...
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Arden Hills, Minnesota, United States Boston Scientific Full timeRecruiter: Spencer Gregory HaleSenior Post-Market Complaint Handling Process Control LeadAbout 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...
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Arden Hills, United States Boston Scientific Full timeAbout 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...
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Senior Post-Market Quality Process Lead
2 weeks ago
Arden Hills, United States Boston Scientific Full timeA leading medical technology company in Arden Hills is seeking a Senior Post-Market Complaint Handling Process Control Lead. This role involves ensuring compliance with regulatory requirements, process control, data analysis, and technical leadership within the complaint handling process. The ideal candidate will have a Bachelor's degree, extensive...
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Post Market Trending Manager
5 hours ago
Arden Hills, United States Boston Scientific Full timeRecruiter: Spencer Gregory HalePost Market Trending Manager - NeuromodulationAbout the role:The Post Market Trending Manager - Neuromodulation will define and execute the vision for Neuromodulation Post Market Quality data analytics and product performance monitoring strategy. They will lead a team of quality engineers and data analysts to achieve data...
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Post Market Trending Manager
7 days ago
Arden Hills, United States Boston Scientific Full timeAbout the role: The Post Market Trending Manager - Neuromodulation will define and execute the vision for Neuromodulation Post Market Quality data analytics and product performance monitoring strategy. They will lead a team of quality engineers and data analysts to achieve data analytics objectives and drive product performance monitoring excellence across...
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Post Market Trending Manager
4 days ago
Arden Hills, United States Boston Scientific Gruppe Full timeOverview Select how often (in days) to receive an alert: Create Alert Select how often (in days) to receive an alert: Onsite Location(s): Arden Hills, MN, US, 55112 Recruiter: Spencer Gregory Hale About the role: The Post Market Trending Manager - Neuromodulation will define and execute the vision for Neuromodulation Post Market Quality data analytics and...
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Principal Product Complaint Analyst
4 days ago
Arden Hills, Minnesota, United States Boston Scientific Full timeAdditional Location(s): N/A; US-MN-Arden Hills; US-MN-Maple GroveDiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt 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...
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Senior Product Complaint Analyst
2 weeks ago
Arden Hills, United States Boston Scientific Gruppe Full timeDiversity - 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...
