Medical Device Quality Investigator & CAPA Lead

West Pharmaceutical Services, Inc; Williamsport (Lycoming County); Hybrid; USD 70,000 - 90,000; Full time

Job summary

West Pharmaceutical Services, Inc. seeks a Technical Investigator to lead investigations of manufacturing deviations and quality events in a medical device manufacturing environment.

You will perform root-cause analysis, review batch records, and help implement CAPA to ensure product quality and regulatory compliance. The role requires at least 3 years in pharma/medical manufacturing, knowledge of ISO 13485/21 CFR Part 820, and strong technical writing and communication skills.

Qualifications

• Associate’s degree in engineering (industrial, chemical), quality or science.
• Minimum 3+ years in medical/pharma manufacturing.
• Knowledge of ISO 13485/21 CFR Part 820 and EU GMP.
• Strong root-cause analysis and problem-solving skills.

Responsibilities

• Lead and support technical investigations of deviations and nonconformances.
• Perform root cause analysis using 5 Whys, Fishbone, and other methods.
• Review batch records and equipment logs to support conclusions.
• Develop and verify corrective and preventive actions.
• Collaborate with multiple teams to resolve quality issues.
• Ensure timely completion of investigations and regulatory readiness.

Skills

Problem solving

Root cause analysis

Technical writing

Data analysis

Communication skills

Statistics

SPC

Cross-functional collaboration

Documentation

Education

Associate’s degree in engineering (industrial, chemical), quality or science

Job description

West Pharmaceutical Services, Inc. seeks a Technical Investigator to lead investigations of manufacturing deviations and quality events in a medical device manufacturing environment.

You will perform root-cause analysis, review batch records, and help implement CAPA to ensure product quality and regulatory compliance. The role requires at least 3 years in pharma/medical manufacturing, knowledge of ISO 13485/21 CFR Part 820, and strong technical writing and communication skills.