Senior Quality Systems Engineer-Complaints

Job Description

The Senior Quality Engineer, Complaints is responsible for assisting in and sometimes leading the evaluation and investigation of complaints and reportable events at several levels. Interfaces closely with internal/external manufacturers, OEMs and local departments to promote quality improvements to both products and quality system processes by initiating and driving corrective and preventive actions. This position requires a thorough understanding of FDA regulatory requirement for complaint handling and MDR reporting. Must be able to communicate and follow-up on event description detail with internal and external customers to evaluate adverse event occurrences. Provides supports in the continuous improvement effort of the VMT (Veran Medical Technologies) quality system for processing complaints to meet FDA, ISO and all applicable international regulatory requirements, and corporate guidelines. Proposes solutions concerning quality discrepancies and process improvements based on data collection, trend analysis and reporting activities. Performs timely closure of product complaints in accordance with established procedures. Lead other QMS projects to improve department processes, procedures, and responsibilities.

Job Duties

* Perform physical device inspection and root cause failure analysis. Interact with cross-functional teams to ensure complaint investigation is completed in a timely manner. Communicate investigation findings to internal and external stakeholders.

* Communicate directly with customers and Olympus field personal to support complaint investigation and resolve customer concern. Use investigation findings to generate written customer communications. Ensure consistent messaging to customers on similar concerns, coordinating with internal stakeholders to review content of communication.

* Review complaint records for accuracy and completeness. Perform complaint file closure in a timely manner. Identify, and assist in removing, roadblocks to timely file closure.

* Provide technical support to Operations technicians, administration staff and production shop floor staff relative to technical investigations. Serve as a technical trainer to the VMT Quality team members as needed.

* Develop solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercise authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.

* Lead complaint investigation and analysis activity. Apply systemic problem-solving methodologies in identifying, prioritizing, communicating, and resolving customer complaint issues with Veran products.

* Work directly with manufacturing sites, subcontractors and OEMs to facilitate corrective and/or preventive actions related to quality problems identified through complaint investigation and/or other sources of quality data. Review and approve manufacturer’s investigations for accuracy and relevance to reported complaints.

* Develop, manage, and run reports in database systems for the purpose of trend monitoring and/or complaint investigation. Leading and facilitate responsible parties to resolve issues. Reviews associated complaint records to ensure the applicable assessment, investigation and analysis records are appropriate and complete.

* Assist local management team in reviewing process implementation and provide recommendation to resolve processing challenges, increase productivity and improve workflow.

* Support local process implementation and global continuous improvement initiatives by serving as a subject matter expert in the field of complaint processing on topics relating to physical device inspection, complaint investigation and data trending.

* Perform other related duties as assigned.

Job Requirements

REQUIRED QUALIFICATIONS: 

* A four-year degree in a technical discipline (e.g., EE, ME, BME, Quality Assurance), or equivalent knowledge and experience.

* Minimum of 5 years’ hands-on experience dealing with regulatory or quality assurance issues in the medical industries. Specific experience in complaint-handling activities and investigation techniques.. Knowledge of Quality System Requirements (21 CFR 820 & 803), and the MDD is required. EUMDR experience desirable.

* Other Considerations (travel/hours availability, etc.): Available to travel to customer sites for product evaluation, ~10%. Available to travel to the manufacturing sites for product training, ~5%. This is primarily an on-site position; a limited hybrid work schedule is possible.

PREFERRED QUALIFICATIONS:

* Previous experience working with different complaint handling systems, e.g., ETQ, SAP, Trackwise, Etc.

* Effective written and verbal communication skills.

* Strong analytical, organizational, communication and interpersonal skills are required.

* Computer literate with experience in Microsoft Office Suite.

* Previous experience working with complaints, CAPAs, NCRs, and other quality management system functions.