Field Assurance Analyst Returns Technician [Must Have Complaint Handling]

Job Title – Field Assurance Analyst Returns Technician [Must Have Complaint Handling]

Location – Warwick, RI

Duration – 6 Months Contract

Client: Medical Device Company

Employment Type: Contract on W2 (Need US Citizens Or GC Holders Only)

On site 5 days a week

Summary/Purpose Of Position

Under the leadership and general supervision of the AQE Lab supervisor and Field Assurance Manager, the Field Assurance Analyst Returns Technician will be responsible for the execution of product complaint sample return evaluation and investigation activities while ensuring complaint handling tasks are completed as required and are compliant with internal procedures and applicable external, industry regulations/standards. Additionally, the technician will perform lab duties to support New Product Development in the AQE Lab.

Essential Duties and Position Responsibilities: /

• Field Assurance Duties
• Documenting complaint product sample return date.
• Decontaminate returned product samples.
• Coordinate 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.

• Support internal and external audits and serve as an active participant as necessary.
• 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
  
  

Key Relationships

Internal Relationships: External Relationships:

• Field Assurance Personnel - BDI Surgery manufacturing facilities
• Advanced Quality Engineers - OEM manufacturing facilities
• R & D Engineers