Hiring for Manufacturing Quality Engineer at Raynham, MA (Onsite)
Job Title : Manufacturing Quality Engineer
Below, you will find a complete breakdown of everything required of potential candidates, as well as how to apply Good luck.
Location : Raynham, MA
Duration : 12 months+
The Manufacturing Quality Engineer will play a key role in supporting existing processes for the casting of medical device components.
Revises / analyzes if the current products and processes (including taken actions or decisions) comply with the regulations, such as QSRs, ISO 13485, etc.
including providing support during internal and external audits.
- Participates in the preparation's activities for / or interactions with regulatory agencies (FDA, JJRC, BSI, etc.).
- Responds to internal or external audit observations related to the quality engineering function.
- Properly establishes and maintains the required documentation of quality assurance activities and / or quality systems.
- Performs periodical audits to the line to evaluate GMPs, production controls, lot segregation, and process audit according to JJPS.
Checks the audit results of the area to ensure that the corrective and preventive actions are adequate.
- Works with NPI and with the manufacturing, process engineering, and manufacturing engineering departments to develop, conduct, and approve product and process validation strategies of products and processes.
- Directs and attends to NCs Revisions meetings as a member of MRB.
- Conducts and supports investigations, bounding, documentation, revision, and approval of the non-conformities (NCs), preventive and corrective actions.
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