Senior 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 post market activities including complaint handling, adverse event reporting, Health Hazard Evaluations (HHE) and field actions.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Assess complaint information provided; evaluate each event for determination if it qualifies as a complaint; escalate as appropriate
• 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, instructions for use (IFU), and any other relevant labeling and/or training materials, and formulate conclusions.
• Review investigation summaries to determine if appropriate and applicable for product failures.
• 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, Engineers, 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.
• Prepare and submit adverse event reports in accordance with appropriate regulatory requirements.
• Assign Health Hazard Evaluations based on complaint and production feedback.
• Evaluate non-conformances to drive appropriate corrective action.
• Be a team player for the achievement of company goals related to complaint processing, escalate to leadership when threshold limits are exceeded.
• Ensure timely closure of complaints to comply with regulatory requirements.
• Prepare and submit final customer correspondence.
• Identify problems and lead projects to improve processes, procedures, and/or practices; recommend solutions, including devising new approaches to problems encountered.
• 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.
• Train other company departments on complaint procedures, processes, and best industry practices as necessary

Requirements

QUALIFICATIONS

• Minimum 4 years of quality experience in medical device industry in a Quality related function.
• Demonstrated problem-solving, critical thinking, and investigative skills. Ability to build stable working internal/external relationships.
• Good knowledge of Good Documentation Practices (GDP) as it relates to complaint filing.
• Ability to manage confidential information with discretion.
• Must be able to work in a team environment, including inter-departmental teams and representing the department on specific projects.
• Good knowledge of medical terms and human anatomy.
• 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.
• Must possess and demonstrate an excellent understanding of medical device requirements including 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR and 1271, ISO 13485, MEDEV 2.12-1, 2017/745 standards

EDUCATION and/or EXPERIENCE

• Requires BA/BS degree in Medical Science, Life Science, Science, Nursing, or Engineering, and a minimum of 3+ years of experience in medical device, or equivalent experience in complaint handling acceptable in lieu of degree.

• Experience in medical device industry 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. $75,000 to $99,000 Full-Time Annual Salary

Benefits

• Health Care Plan (Medical, Dental & Vision)
• Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)
• Family Leave (Maternity, Paternity)
• Short Term & Long Term Disability
• Free Food & Snacks
• Wellness Resources
• Stock Option Plan