Field Assurance Analyst Returns Technician [Must Have Complaint Handling]

Essential Duties and Position Responsibilities

• Documenting complaint product sample return date.
• Decontaminate returned product samples.
• Cook up product transfers to/from external manufacturing sites.
• Evaluate and investigate product sample returns to assist in determining the most probable root cause of the complaint and document accurate investigation findings in the complaint handling system.
• Maintain the Field Assurance (Bio-Hazard) Lab area. Ensure Lab is clean and in good order. Items are properly labeled as potential biohazard material as received.
• Support lab biohazard waste disposal in conjunction with facilities.
• Manage and document thorough and accurate complaint records while ensuring they are processed in a uniform and timely manner and are compliant with Good Documentation Practices (GDP).
• Identify and escalate quality issues and identify changes in (MDR/MDV) reportability based on sample return condition.
• Serve as an active participant during internal and external audits.
• Complete mandatory training by established due dates and always maintain training compliance.
• Adhere to departmental processes and systems to ensure regulatory compliance.

AQE Lab Duties

• Assists with the inspections and evaluations for new product development projects and first article inspections to support the component qualification process.
• Perform accurate mechanical, physical, and visual inspections of raw materials and components on time, as per Inspection Plans and Specification Requirements Read and interpret specifications and part prints, including Geometric Dimensioning & Tolerances (GD&T).
• Review and complete inspection records, lab requests, and device history records as per GMP requirements.
• Performs and coordinates inspections based on business priorities and coordinates with other departments as needed.

Qualifications, Knowledge, and Skills Required

• Associates degree required. BS/BA preferred.
• 2-5 years of experience in complaint handling, quality control, manufacturing or related functions in the medical device, pharmaceutical, biotech or equivalent industry.
• Sound written and verbal communication skills are required.
• Proficiency in common computer applications such as Microsoft Office (Excel, Word and Outlook).
• Familiarity with medical, anatomical and physiological terminology preferred.
• Familiarity with the medical device industry and regulatory requirements preferred.
• Duties require basic knowledge of mechanical and physical inspection techniques. (Calipers, micrometers, blueprint reading, etc.)
• Duties require knowledge of inspection/sampling techniques and familiarity with ANSI/ASQZ1.4.
• Knowledge of FDA Quality System Regulations, ISO 9000, and ISO 13485