Quality Engineer
1 week ago
- Identify, document, and track hardware defects and issues using appropriate tools and methodologies.
- Perform root cause analysis of hardware defects and propose effective solutions to prevent recurrence.
- Continuously improve and streamline the quality assurance processes and methodologies to enhance efficiency and effectiveness.
- nd approval of ECO (Engineering Change Orders), (EDA) Engineering Deviation Authorization, and EDA Extensions.
- Support PSE (Product Support Engineer) Team in conducting RCCM (Root Cause-Counter Measures) for failed parts/spares in the field.
- Support the (RI) Receiving Inspection Team by developing both FA (First Article) and (IP) Inspection Plans by uploading these approved plans into SAP.
- Support the CAPA (Corrective Action Preventive Action) Team when required.
- Participate in internal audits / on-site supplier quality audits and supplier visits to continually monitor supplier capability and compliance when required.
- Support the Revision of (WI) Work Instructions, (OP) Operating Procedures as required.
- Maintain a safe work environment and utilize appropriate safety equipment.
- Maintain internal quarantine parts/spares until the necessary inspection of those materials have been completed and approval given for transfer to the warehouse prior to manufacturing.
- 3-7 years of experience (manager does not want someone too senior).
- Background in manufacturing and working with MES systems.
- Experience in working in a manufacturing/quality environment that involved some type of physical hardware component (for example, not chemicals).
- Experience directly with ISO 9001.
- Experience with SAP (required).
- Experience with Oracle Cloud PLM (plus skill).
- SAP Quality Module (plus skill).
- Experience working in a medical devices or life sciences space.
- Experience with ISO 13485 (specific to life sciences/med devices industry).
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