Quality Engineer: Validation, CAPA & Compliance

RXinsider LTD.; Williamsport (Lycoming County); On-site; USD 75,000 - 115,000; Full time

Job summary

West Pharmaceutical Services, Inc. seeks a QA professional to lead quality assurance activities supporting new product development and validation. You will perform audits, CAPA, and support ISO 13485 compliance across manufacturing, engineering, and supply chain.

You will work with customers and internal teams to investigate complaints, develop validation protocols (IQ/OQ/PQ), and ensure proper documentation and adherence to quality policies. Travel up to 10% may be required.

Qualifications

• Bachelor’s degree preferably in technical discipline; Science, Engineering, Quality Assurance, or a related field.
• Strong knowledge of statistics and use of Minitab.
• Excellent communication and problem solving skills.
• Familiarity with SAP or MasterControl is a plus.

Responsibilities

• Plan, schedule, execute & communicate all items regarding quality issues, complaints, validations & other projects to QA Manager and/or other interested parties.
• Provide technical assistance for developing and maintaining measurement routines for the vision measuring system.
• Provide quality assistance in support of new product development and validation.
• Support customer complaint process and CAPA actions.
• Perform audits of departments and participate in customer/supplier/corporate audits.

Job description

West Pharmaceutical Services, Inc. seeks a QA professional to lead quality assurance activities supporting new product development and validation. You will perform audits, CAPA, and support ISO 13485 compliance across manufacturing, engineering, and supply chain.

You will work with customers and internal teams to investigate complaints, develop validation protocols (IQ/OQ/PQ), and ensure proper documentation and adherence to quality policies. Travel up to 10% may be required.