Complaints Manager

This individual leads a team responsible for the development, implementation and maintenance of processes associated with complaint the complaint handling process (intake, evaluation/review, failure investigations, adverse event reporting) pertaining to the Minerva Surgical products.

This individual will be responsible for the integrity of the complaint handling process and ensure that investigation conclusions are clear, supported, robust 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 product improvements.

DUTIES AND RESPONSIBILITIES

• Designs, implements, and maintains complaint investigation processes and procedures, including writing requirements and process documentation.
• Actively participates in the complaint intake process.
• Ability to solve complex problems by developing novel failure investigation test methodologies and associated processes and training materials.
• Serve as a Subject Matter Expert for complaint investigations which includes both internal functional support and external customer support with respect to complaint investigation findings and associated improvements initiatives.
• Provide complaint investigation and quality engineering expertise and consultation to significant / complex projects.
• Ensure timely completion of complaint failure investigations and communicate with management and team members as required to ensure appropriate actions are taken to maintain/restore timeliness goals.
• Ensure all complaint investigations failures have been adequately risk-assessed and initiate and champion new risk assessments as required.
• Own and lead investigation and root cause analysis efforts for Corrective and Preventive Actions System (including Supplier Corrective Actions) when necessary.
• Develop, compile and present complaint investigation process summary metrics to Management Representative (Management Review Meetings) and Senior and Executive Management, as necessary (as Deputy Management Representative)
• Compile Quality Metrics and present at CAPA Council Meetings
• Communicates complaint investigation findings to appropriate personnel and escalates to Senior Management on critical issues as necessary
• Contribute to product safety, product quality, and customer satisfaction related decisions (both data-based and risk-assessment-based decisions)
• Ensure complaint investigation documentation and records are complete and in compliance with regulatory requirements.
• Participate and support internal, external audits and inspections as needed
• Participates in external regulatory inspections. Ensures that pre and post-inspection activities are completed including record review, training, logistics, etc.
• Prepares responses to audit nonconformities for review by senior management with respect to complaint investigations.

PREFERRED QUALIFICATIONS:

• Effective oral and written communication skills
• Strong interpersonal skills including relationship building, conflict resolution
• Demonstrated ability to manage, develop and mentor employees
• Demonstrated knowledge of implementing new test methods and associated validation strategy and documentation
• Ability to work well under pressure, to handle multiple projects, and to meet aggressive deadlines
• Strong attention to detail and organizational skills
• 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, Videoconferencing, EQMS
• Extensive knowledge of FDA Quality Systems Regulations 21 CFR Part 820, Medical Device Reporting 21 CFR 803, Report of Corrections and Removals 21 CFR 806, Recall 21 CFR Part 11, EN/ISO 13485 Quality Management Systems Medical Devices, EN/ISO 14971 Risk Management.
• International Regulations for Medical Devices such as: EU Medical Device Directive, EU Medical Device Regulation, Canada SOR/98-282 Medical Device Regulation
• Extensive knowledge and experience conducting Adverse Event Reporting: eMDR (US), MDV(EU), MPR(Canada)
• 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:

• BS/BA in Engineering discipline or related field preferred.
• Experience leading and building a strong Complaint Handling/Failure Investigation team.
• Professional certification preferred e.g. CQA, CQE, CRE, Lean Six Sigma, Six Sigma Black Belt, etc.
• Minimum of 8-10 years of progressive experience leading complaint intake/handling/failure investigation teams and demonstrated history of effective root cause determination in complex electro-mechanical, software-driven medical devices in a high-volume manufacturing environment
• Must possess solid background of establishing new failure investigation processes, test protocols, and procedures