Senior Complaints Specialist

Position Scope:

The Senior Complaint Specialist will assure department compliance with ISO and FDA, EU MDR and at least MDSAP requirements through review of global complaint files as a complaint specialist. This is a hands-on position responsible for full-cycle complaint handling including initial response, assessment, vigilance reporting, investigation, resolution, and customer complaint close-out. The Senior Complaint Specialist will be responsible for gathering relevant information and data in order to solve quality-related problems, resolve issues by identifying and applying solutions from acquired technical experience and guided precedents, the evaluation of returned product for failure and root cause analysis, and assist with CAPA management and effectiveness for multiple organization sites.  Ensure process is compliant with regulatory requirements and business needs in terms of receiving, documenting, investigating, resolving and responding to complaints. Manage metrics reporting

Strategic Focus Areas:

• Perform all activities within the requirements of the Quality System and 21 CFR Part 820 and 211, ISO 13485, EU MDR 2017/745 
• Participate in projects and activities which support the growth efforts of the Company
• Maintain cost discipline within assigned programs
• Implementation of Post Market Surveillance of products
• Implementation of processes and mechanisms to facilitate gathering of data to assist with any potential recall and/or reporting actions
• Participates in internal audits and external quality system audits conducted by regulatory agency representatives
• Monitoring of complaints for product trends and notify management of events requiring immediate action
• Follow-ups with applicable complaint sources (study coordinators, physicians, pharmacies, sales reps, and hospitals) to obtain applicable information pertaining to reported events
• Support Global Quality continuous improvement activities

Specific Responsibilities:

• Comply with the corporate Quality System
• Develop and maintain efficient methods for regularly reporting to management the status of the product quality with respect to Quality objectives and goals
• Review customer complaints received for Medical Device Reports (MDRs), FDA and ISO requirements
• Manage the full life cycle of global customer complaints for multiple sites through collaboration with internal and external stakeholders including review, maintenance of complaint files and compliance with policies regulatory requirements and procedures  and Making sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management
• Utilize the complaint database system to process complaints, create and measure Quality metrics and vigilance reports
• Leads complaint investigations, performs root cause analysis, prepares detailed investigation reports and implements corrective actions as needed
• Assists with management of CAPAs, Change Controls, Internal and External Audit programs and maintain associated tracking logs utilizing the Electronic Quality Management
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements
• Facilitates the Risk Management Process in accordance with the latest version of ISO 14971; ensures integration of risk management outputs with design, process, and regulatory requirements
• Participate with continuous improvement efforts specific to the global complaint handling process
• Assist with complaint metrics presentations.
• Provide support for the development of trending analytics and reporting of complaint trends and submit to management to ensure early detection of potential quality issues. Evaluates risk and develops/implements appropriate solutions, escalating critical matters to management while resolving non-critical matters independently
• Assist with the retrieval of on-site records for customer complaint investigations
• Report to the organization site when needed for audits or other tasks assigned
• Act as the SME trainer of other QA personnel
• Perform any other duties or responsibilities as assigned 

Job Complexity:

The position works on diverse and complex clinical product quality issues which require gathering product Quality data and performing data analysis for product performance across multiple organizational sites.  Additionally, this individual will assist management with the management of CAPAs and Change Controls.    

Supervisory Responsibilities:

None

Required Qualifications:

• Bachelors’ degree in engineering or related discipline or equivalent experience.
• 3+ years of direct responsibility for complaint handling and documentation  
• Prior experience with management of process change-controls, CAPAs, Internal/External and Supplier Audits

• Knowledge of GMP/ISO requirements, specifically current ISO 13485 Medical Devices
• Experience and knowledge of GMP/ISO regulations, including but not limited to 21 CFR Part 820 and 211, ISO 13485, EU MDR 2017/745

• Familiarity with the principles of Design Control
• Familiarity with investigation techniques
• Strong knowledge of statistical process control methods and techniques
• Proficient with statistical methodology and statistical software tools
• Working knowledge of Six Sigma a plus but not required
• knowledge of medical device reporting regulations combined with broad knowledge of quality principles

Desired Experience, Knowledge, and Skills:

• Demonstrate good documentation practices (cGDP)
• Ability to interact and communicate positively and professionally with internal and external customers
• Exhibit flexibility and adaptability by managing assignments in accordance to priorities and be able to alter a course of action when necessary 
• Strong analytical, problem solving, planning, and organizational skills 
• Ability to evaluate and interpret the data and write conscious reports
• Proficiency in word processing, spreadsheets, and databases
• Good presentation, organization, and communication skills
• Ability to work autonomously, effectively manage time and deliver results on time 
• maintenance of up-to-date knowledge of all applicable international regulation and regulatory guidance

We are an equal opportunity employer, and we do not tolerate discrimination based on characteristics such as age, gender, gender identity and expression, genetic status, sexual orientation, race, ethnicity, national origin, religion, disability, military status, family status, or any other protected category under federal, state, or local law.