The Quality Engineer will report to the Quality Assurance Manager. S/he represents Quality within cross-functional teams to coordinate documentation and ensure compliance for instrument IQ/OQ, assay Verification/Validation activities and Risk Management. Position responsibilities also include monitoring Engineering Change Controls and data trending to provide corrective action solutions that drive continuous improvement.
Job performance will involve a variety of activities including:
- Work in collaboration with product development to ensure that the designs, procedures and outcome of the project are acceptable in quality.
- Support the creation and the maintenance of Risk Management plans including dFMEAs, pFMEAs and Control Plans.
- Write or review and approve equipment IQ/OQ and assay Verification/Validation studies in collaboration with cross-functional teams.
- Conduct and support investigations of manufacturing nonconformities, recommend, develop and implement effective corrective actions.
- Applies statistical methods for analyzing data to evaluate the current process and process changes and solve problems.
- Coordinates, collects, analyzes and distributes quality monthly and quarterly metrics
- Participates on audits conducted by regulatory agencies and/or customers.
- Participates in supplier evaluation and selection assessments.
- Maintains a working knowledge of industry standards. Knows and follows the ISO quality system guidelines.
- Performs external vendor audits to ensure ISO and/or FDA compliance.
- Additional responsibilities may be assigned as needed.