Quality Systems Specialist II (Information Technology)

JOB PURPOSE:

This position is responsible for managing the Customer Complaint Process and Corrective Action / Preventative Action (CAPA) system to ensure continuous improvement of the Quality System. Overseeing the customer complaint process by receiving device complaints, completing investigations, and communicating results with customers, and supporting daily quality activities such as non-conformance reports and production training. The Quality Systems Specialist is required to possess strong computer skills and a high-level of written and verbal interactive communication skills.

ESSENTIAL DUTIES:

• Responsible for managing, tracking, and investigating CAPAs open within the Quality System. Supports root cause investigations, implementation of corrective/preventative actions, and verifies the effectiveness of the actions.
• Ensures CAPAs are investigated/completed in a timely manner and are compliant with documented procedures and regulatory requirements.
• Primary contact for all customer experience reporting and complaint handling activities related to commercial and investigational products. This individual is responsible for independently receiving, documenting, investigating, and coordinating responses on product complaints.
• Ensures timely investigation of and response to product complaints in compliance with internal, customer, and regulatory requirements. This involves initiating and participating in investigations and corrective action arising from product complaints. Collaborates with Customer Service, Engineering/Manufacturing, Quality Assurance, Regulatory Affairs, and end customers/users in these investigations.
• Maintains current and complete complaint files.
• Performs collective analyses of product complaints for trends and identification of potential corrective or preventive actions.
• Prepares reports and data analysis for periodic management reviews
• Supports the investigation and closure of non-conformance reports
• Participate in production training activities including, but not limited to new employee orientation, conducting training audits, and retraining as necessary.
• Assists in Complaint and CAPA charting, trending and reporting.
• Other duties as required.

QUALIFICATIONS (Education/Experience/Knowledge, Skills & Abilities) Required:

• College Degree or equivalent work experience preferred.
• Ability to read, analyze, and interpret technical procedures and regulations.
• Risk Management (FMEA or other tools)
• Expertise in Microsoft Office applications and charting programs.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
• Accuracy, detail-oriented, and ability to multi-task and prioritize tasks with strict deadlines.
• Good customer service/phone skills and flexibility for handling a wide range of activities.
• Set the example by actively contributing to department and company goals.
• Take initiative and seek additional training or direction as needed.
• Build quality into work. Ensure processes are consistent with quality objectives. Be aware of current quality levels versus target levels.
• Develop and achieve departmental/company goals and controls. Make suggestions for improvement in areas of cost reduction, processes, quality and productivity.

WORKING CONDITIONS:

Requires light physical activity performing non-strenuous activities of a decision-making nature. Requires moderate periods of sitting, using a computer, as well as periods of standing and walking around the manufacturing cleanroom areas where specific gowning requirements are in place. In addition, it is necessary to attend occasional management/project meetings.