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Quality Assurance Complaints Manager

Company: Minerva Surgical
Location: Santa Clara
Posted on: January 24, 2023

Job Description:

POSITION SUMMARY: This individual leads a team responsible for complaint call intake, investigation, product returns, return product analysis, complaint closure, and the monitoring and reporting on the performance of our products. This individual will be responsible for the integrity of the complaint handling process and ensuring that investigation conclusions are clear, supported, robust, timely and compliant. This individual will ensure that best practices in complaint investigation processes and associated root cause determination protocols and testing methodologies are carried out. Additionally, this individual must have strong analytical skills and effective communication across all levels of the company and demonstrate strong teamwork and collaboration across several functional areas to drive continuous improvements. DUTIES & RESPONSIBILITIES:

  • Design, implement, and maintain complaint handling and investigation processes and procedures. Formulate and recommend solutions in the application of complaint handling strategies
  • Lead the Complaint Handling team as a people manager, recruit, motivate the team and drive defined performance outcomes. Develop harmonized goals and objectives.
  • Ensure complaint intake, and investigation documentation and records are complete, timely and in compliance with regulatory requirements. Ensure all complaint investigations failures have been adequately risk-assessed and initiate and champion new risk assessments as required.
  • Review and approve all complaints for content, closure.
  • Support validation, implementation, and maintenance of an electronic QMS Complaint Handling System (IQVIA SmartSolve) and the transition from a paper-based system
  • Generate reports on complaint data for routine analysis, management review, and CAPA Council using advanced data visualization/analytical tools (e.g. TIBCO, Tableau, Power-BI).
  • Participate in senior committee that reviews all potential adverse events for reportability
  • Communicate complaint investigation findings to appropriate personnel and escalate to Senior Management on critical issues as necessary
  • Work with Marketing, Sales and Regulatory Affairs to establish and maintain feedback systems and other post-market surveillance processes that may be a complaint data source
  • Provide training to customer-facing employees on our complaint handling process
  • Participate and support internal/external audits and regulatory inspections as needed
  • Own and lead investigation and root cause analysis efforts for any Corrective and Preventive Actions (CAPAs) related to the Complaint Handling process.
  • Perform documentation, leadership and oversight of any recall or field correction activities
  • Evaluate current regulations, standards, and guidance impacting Post Market Surveillance systems on an ongoing basis and implement solutions to ensure continued regulatory compliance. PREFERRED QUALIFICATIONS: Preferred Requirements:
  • Effective oral and written communication skills
  • Strong interpersonal skills including relationship building, conflict resolution
  • Demonstrated ability to manage, develop and mentor employees
  • Strong attention to detail and organizational skills
  • Advanced experience/aptitude with TIBCO or other data visualization tools for analysis.
  • Project management utilizing analytical, technical, and problem-solving skills.
  • Able to perform multiple complex tasks/projects and prioritize workloads and activities
  • Excellent computer skills including but not limited to: Microsoft Office, EQMS
  • Extensive knowledge of 21 CFR Part 820 - FDA Quality Systems Regulations, 21 CFR Part 803 - Medical Device Reporting, 21 CFR Part 806 - Report of Corrections and Removals, ISO 13485 Quality Management Systems Medical Devices, ISO 14971 Risk Management.
  • Extensive knowledge and experience conducting Adverse Event Reporting eMDR (US)
  • Experience documenting and conducting Recalls, Field Safety Corrective Actions/Field Safety Notices
  • Ability to lift a minimum of 40 pounds. Preferred Education and/or Job experience:
  • Bachelor's degree or equivalent
  • Technical aptitude to learn how Minerva products operate and are used, female anatomy and the products common failure modes, in order to be able to document complaints
  • 8+ years experience in a quality role in the medical device industry, preferably with a Class III medical device.
  • Understanding of design controls, risk management, complaints/MDRs, RGAs, CAPAs.
  • Knowledge of Good Manufacturing Practices and Good Documentation Practices Powered by JazzHR

Keywords: Minerva Surgical, Santa Clara , Quality Assurance Complaints Manager, Executive , Santa Clara, California

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