Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Responsibilities:
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.
and 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.
Requirements:
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).