Quality Assurance Engineer (ISO 9001 Compliance)
Brooks Automation is seeking a Quality Assurance Engineer to be responsible for the continuous improvement of the Quality Management System of a dynamic and complex robotic engineering and manufacturing environment. You will be a data steward for the purpose of auditing and organizing the organizations policies, processes and work instructions to ensure they are current and fit for use in an ISO 9001 compliant environment. You will plan, conduct and report internal quality audit results and log and track corrective actions in the corrective actions database. Facilitate Document Change Orders (DCO) to improve, update, or obsolete QMS document assets. Assist with preparation for customer audits, customer questionnaires and external audits to ensure successful ISO 9001 audits and continued compliance in all areas of the ISO 9001 standard. Assist and coordinate with the training coordinator to create, modify or suggest retraining when training noncompliance’s occur or as required.
- Schedule, plan, conduct and report internal audits using master scheduler and Microsoft Teams.
- Export data from Oracle Quality Cloud, import to analyze data in Microsoft Excel and track and status internal audits and corrective action progress toward closure.
- Update or change QMS documentation as required by audit findings or internal continuous improvement objectives using the DCO process.
- Monitor and measure Document Change Order status (DCO) for continuous QMS improvements.
- Assist in the follow up and status of internal, external or customer audit corrective actions.
- Communicate audit trends using PowerPoint for monthly quality meetings.
- Assist with preparation for local internal, customer, and external audits as needed.
- Drive and facilitate functional area meetings to collect information and respond to customer quality/qualification surveys.
- Effectively communicate and collaborate with colleagues and customers.
- B.S. or equivalent working experience in a technical or engineering discipline.
- Minimum of 5 years of experience in a Quality Assurance role focusing on ISO 9001 compliance standards and internal auditing methods.
- Knowledge of various quality system methodologies such as PDCA (Plan Do Check Act), PQP (Process Quality Plan), FMEA (Failure Analysis), Root Cause/5 Why’s, 8Ds and Corrective Action plans.
- Microsoft Office proficiency (Excel, Word, PowerPoint, Visio).
- ISO 9001 Internal Auditor Certification.
- Agile PLM document management system experience.
- Oracle Cloud based Quality applications (corrective actions database.
- SharePoint file management and navigations skills.
- Project management skills.