Senior Post-Market Complaint Handling Process Control Lead

Recruiter: Spencer Gregory Hale

Senior Post-Market Complaint Handling Process Control Lead

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.

Minimum requirements:

• 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

Minimum Salary: $82600

Maximum Salary: $156900

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.

BSC is an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.