Supplier Quality Engineer
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Job Location:
Newark, DE - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Supplier Quality Engineer (Sustaining)
6 months to start
6 months to start
Newark DE - Onsite
Environment:
We are seeking a Supplier Quality Engineer with 5 8 years of experience to support sustaining activity across manufacturing and supplier processes. This role will focus on creating and developing test methods to ensure the supplier and client are aligned in their processes. This role is to support a sustaining team as FTEs transition to a remediation effort.
Skills & Experience MUST HAVE
Evaluate CMs on their ability to perform root cause analysis track defects and suggest manufacturability improvements rather than just certifications.
Ensure design prototyping and final product meets regulatory requirements.
Write incoming/recieving quality instructions (IIs) while working with suppliers to ensure components meet established standards.
Coordinate any effort needed to provide the supplier with fixtures if needed to do inspection testing.
Create and develop test methods making sure the test method at the supplier and client are aligned.
Must have overseen OEMS and CMs
Create Instruction Inspection methods to test supplier components at Hologic.
Coordinate any effort needed to provide the supplier with a fixture if needed to do inspection testing.
Coordinate with R&D and/or MFG Engineering revising raw material specifications to including missing inspection criteria.
Execute and support IQ/OQ/PQ for manufacturing and supplier processes
5 8 years of experience in Manufacturing Engineering or Quality Engineering within medical devices
Statistical Process Controls (CPK PPK SPC Charts)
Bachelors degree in engineering.
Preferred Experience:
CAPA investigations and root cause analysis.
13485 Auditing experience and certification.
Environment:
We are seeking a Supplier Quality Engineer with 5 8 years of experience to support sustaining activity across manufacturing and supplier processes. This role will focus on creating and developing test methods to ensure the supplier and client are aligned in their processes. This role is to support a sustaining team as FTEs transition to a remediation effort.
Skills & Experience MUST HAVE
Evaluate CMs on their ability to perform root cause analysis track defects and suggest manufacturability improvements rather than just certifications.
Ensure design prototyping and final product meets regulatory requirements.
Write incoming/recieving quality instructions (IIs) while working with suppliers to ensure components meet established standards.
Coordinate any effort needed to provide the supplier with fixtures if needed to do inspection testing.
Create and develop test methods making sure the test method at the supplier and client are aligned.
Must have overseen OEMS and CMs
Create Instruction Inspection methods to test supplier components at Hologic.
Coordinate any effort needed to provide the supplier with a fixture if needed to do inspection testing.
Coordinate with R&D and/or MFG Engineering revising raw material specifications to including missing inspection criteria.
Execute and support IQ/OQ/PQ for manufacturing and supplier processes
5 8 years of experience in Manufacturing Engineering or Quality Engineering within medical devices
Statistical Process Controls (CPK PPK SPC Charts)
Bachelors degree in engineering.
Preferred Experience:
CAPA investigations and root cause analysis.
13485 Auditing experience and certification.
