Early career opportunity at an established, expanding manufacturer of critical medical device components used in minimally invasive surgical procedures. The manufacturing oriented Quality Engineer will support the implementation of a Quality Management System (QMS) and ensure compliance to ISO13485:2016.
- Support the maintenance of the QMS, ensuring its continuing suitability, adequacy and effectiveness.
- Own the Corrective and Preventive Action, Returned Material Authorization, and Nonconforming Material Systems.
- Manage the Equipment Qualification and Validation System (including IQ, OQ and PQ, etc).
- Work with Manufacturing and Engineering to draft and execute protocols.
- Lead the Materials Review Board process where applicable.
- Perform First Article Inspections with QC Personnel.
- Where applicable, create and execute Measurement System Analysis (Gage R&R).
- Work directly with customers to support technical issues and continuous improvement.
- Support day to day operations to drive Key Process Indicator improvements and business objectives.
- Supports the Approved Supplier List Evaluations, Reporting and Feedback.
- Create and edit Standard Operating Procedures, Work Instructions and Forms.
- Perform Product Quality Inspections as needed.
- Perform Measuring and Monitoring Equipment Calibration as needed.
- Perform training as needed.
- 2 to 5 years of related experience in medical device quality engineering or manufacturing.
- Experience in medical component or medical device manufacturing required.
- Full understanding of a QMS and conformance to ISO13485:2016.
- Proficient using metrology tools (hand devices, vision systems, microscopes, non-contact devices, profilometer).
- Basic proficiency in reading drawings and blueprints.
- Ability to read, listen and communicate effectively in English, both verbally and in writing.
- Ability to navigate a computer ERP system, in certain modules, and perform data entry, data retrieval.
- Computer Skills in MS Word, Excel, PowerPoint, Visio are required; QMS software experience is a plus.
- Experience in customer, registrar or FDA audits/inspections is a plus.
- The flexibility to take on responsibility and work beyond the scope of essential duties.
- BS in a related field.