About Us Founded in 2015 to develop the world’s first industrially scalable laser metal additive manufacturing solution, VulcanForms is reshaping how the world manufactures critical products.
About the role
The hourly pay range for this position is $22.60-$31. This role shall also include a pay differential of 10% on any applicable shift not included in the standard base-pay shifts.
What they're looking for
- 3+ years of experience in Med Device Manufacturing with direct responsibility for Final Release or Document Control
- Proficiency in reading and interpreting engineering drawings, blueprints, and technical specifications
- Demonstrated experience reviewing Device History Records (DHRs) and Batch Records for completeness and compliance
- Experience initiating, documenting, and tracking nonconformances, deviations, and CAPAs to closure
More about this role
The Final Release Specialist II supports the batch final release processes and performs functions necessary to ensure that all relevant manufacturing records and documentation are assembled, reviewed, and completed in a compliant efficient manner. This position requires attention to detail and must be performed in accordance with standard operating procedures, as well as all applicable requirements. This is a second shift role with the hours of Monday through Friday, 3pm - 11pm.
- Maintain the flow of work, to include but not limited to, the setup of technical records for review, inspection,
- Assign and track to completion all work in progress (WIP) records.
- Attend weekly planning meeting as the Quality Assurance representative and work with Operations, Customer Service, Distribution, Engineering and all other cross functional departments to ensure commitments and customer needs are met.
- Knowledgeable in ERP and QMS electronic systems
- Able to identify and initiate nonconformances.
- Responsible for the QA review of data entry, documentation, and technical and final release records.
- Ensure that each batch is inspected per specification, physical product is verified prior...
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