Complaints Analyst

The primary responsibility of this position is performing daily duties in the complaint and reporting system Quality Management System to ensure regulatory and quality compliance to applicable medical device regulations and standards, internal procedures, quality objectives, and strategic goals of the company, are completed timely and orderly. The individual will coordinate complaint investigations, determine complaint reportability, trend key performance metrics, present summary complaint data internally, both for self and team members, and enter investigation results into the tracking system.

Essential Duties and Responsibilities

• Contribute to the company's investigations of customer complaints; log customer complaints, analyze, evaluate information provided and conduct additional investigation as needed.
• Summarize findings, including a review of the investigation, product analysis, imaging review, device history records, instructions for use (IFU), and other relevant labeling and/or training materials.
• Be a team player for the achievement of company goals related to complaint processing, escalate to leadership when threshold limits are exceeded.
• Ensures complaints are thoroughly investigated per domestic and international requirements and that all company policies, operating procedures, and work instructions are followed.
• Communicate with Product Managers, Sales Representatives, and Distributors to obtain additional information when required for complaint investigations. Be a resource of knowledge to respective teams for strategizing and implementing corrections. Identify trends of adverse events.
• Ensure timely closure of complaints to comply with regulatory requirements.
• Review complaints to determine reportability of complaints to FDA and international regulatory authorities and document on decision tree; escalate to management when necessary.
• Prepare and review initial draft of Medical Device Reports (MDRs) and international Vigilance Reports ensuring timely transmission.
• Author customer response letters for management review and submission.
• Review investigation summaries to determine if appropriate and applicable for product failures.
• Analyzes complaint data in support of management reviews, product improvement activities, and continuous improvement; presents summary information to cross functional teams as needed.
• Provide support during regulating body audits including FDA inspections and ISO audits.
• General maintenance of procedures focused around Quality Assurance.
• Train other company departments on complaint procedures, processes, and best industry practices as necessary

Requirements

The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Minimum 2 years of quality experience in med device industry in a Quality related function.
• Must be able to think logically, evaluate and make decisions based upon procedures, regulations, specifications, standards, and scientific information
• Ability to understand engineering drawings
• Training in or good working knowledge of root cause analysis tools
• Advanced Excel Skills (VLOOKUP, Pivot Tables, forms, data analysis, etc)
• Advanced PowerPoint skills (i.e. Excel chart linking and template design)
• Effective technical writing and verbal communication skills
• Experience as a lead contributor to project execution
• Preferred knowledge of US and International Medical Device Regulations and Standards including but not limited to FDA 21 CFR 803 (MDR), FDA 21 CFR 820 (QSR), MEDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485.

Education and Experience

• High School diploma is required. BA/BS in associated discipline desirable.
• 2+ years in medical device in a Quality related field, Complaint Handling experience preferred.

For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).

ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.

Salary Range

Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity. $30 to $37 Full-Time Hourly Range