Technical Investigator - Medical Device Quality & CAPA

RXinsider LTD.; Williamsport (Lycoming County); Hybrid; USD 75,000 - 110,000; Full time

Job summary

West Pharmaceutical Services is seeking a Technical Investigator to lead investigations of manufacturing deviations, nonconformances and quality events in a medical device manufacturing setting. You will perform root cause analyses, review documentation, and collaborate across functions to implement robust CAPAs and prevent recurrence.

The role requires strong knowledge of quality systems, data analysis, and excellent technical writing.

Qualifications

• Minimum 3+ years’ work experience in medical/pharma/high-volume regulated manufacturing.
• Strong knowledge of ISO 13485/21 CFR Part 820 and EU GMP; working with quality systems.

Responsibilities

• Lead and support technical investigations related to manufacturing deviations, nonconformances, customer complaints, process failures, equipment issues, documentation discrepancies, and quality events.
• Conduct root cause analysis using 5 Whys, Fishbone, process mapping, and other methods.
• Review batch records, device history records, equipment logs, and process data to support conclusions.
• Interview operators and subject matter experts to gather accurate information.
• Develop and verify CAPAs to address root causes and prevent recurrence.

Skills

Quality systems

Injection molding

Technical writing

Root cause analysis

Statistics & data analytics

Communication skills

Computer proficiency

Education

Associate’s degree in engineering/quality or science

Tools

8D problem solving

A3 reporting

SPC/data analytics tools

Job description

West Pharmaceutical Services is seeking a Technical Investigator to lead investigations of manufacturing deviations, nonconformances and quality events in a medical device manufacturing setting. You will perform root cause analyses, review documentation, and collaborate across functions to implement robust CAPAs and prevent recurrence.

The role requires strong knowledge of quality systems, data analysis, and excellent technical writing.