Field Assurance Lab Technician

Job Summary

Position : Field Assurance Lab Technician
Location : Warwick, RI
Duration : 12 Months
Total Hours/week : 40.00
1st Shift
Client: Medical Device Company
Job Category: Healthcare
Level of Experience: Entry-Level
Employment Type: Contract on W2 (Need US Citizens or GC Holders Only)

Essential Duties and Position Responsibilities

• Documenting complaint product sample return date.
• Decontaminate returned product samples.
• Capture 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.

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