Senior Supplier Quality Engineer
$61.67 - $66.67 per hourCynet Systems
Job Overview: Pay Range: $61.67hr - $66.67hr Requirement/Must Have:
- Bachelor's degree in Engineering or a scientific field.
- At least 4+ years of engineering experience in a highly regulated industry (e.g., Medical Device, Aerospace, and Automotive).
- Knowledge and understanding of FDA's 21 CFR Part 820, ISO13485, ISO9001, and other International Regulatory Standards.
- Experience and/or proficient knowledge of Design Controls and test method development/validations.
- Demonstrated experience driving component testing, test method validations, and testing/validating equipment.
- Experience with statistical techniques and tools such as Gage R&R, Statistical Process Control, or Process Capability Studies.
- Knowledge of GD&T and ability to read and interpret drawings.
- Good understanding of process validations (IQ, OQ, PQ).
- Good understanding of manufacturing processes (i.e., injection molding, extrusion, machining, etc.).
- Lead and perform gage studies, process capability studies, and supplier process validations related to critical component features based on risks identified in FMEAs.
- Develop and validate test methods, which can encompass creating inspection routines on optical measurement equipment and design and creation of inspection fixtures using SolidWorks.
- Provide engineering support to Receiving Inspection on component test methods and investigations.
- Manage supplier-related non-conformances.
- Manage supplier corrective action requests (SCAR) from initiation to closure.
- Report on supplier part qualification status at recurring cross-functional project meetings.
- Collect and analyze Quality metrics relating to Supplier Quality.
- Communicate supplier quality risks to upper management during Management Review and project meetings and identify solutions to mitigate risks.
- FDA 21 CFR Part 820.
- ISO13485.
- ISO9001.
- Design Controls.
- Test method development.
- Gage R&R.
- Statistical Process Control.
- Process Capability Studies.
- Root cause analysis.
- CAPA.
- GD&T.
- SolidWorks.
- IQ/OQ/PQ.
- Strong verbal and written communication skills.
- Ability to communicate effectively with stakeholders.
- Ability to conduct effective root cause analysis.
- Ability to drive non-conformance investigations.
- Ability to multitask while maintaining high attention to detail.
- Ability to achieve results in a cross-functional team environment.
- Ability to build strong relationships with internal and external partners.
Vacancy posted 5 days ago
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