Senior Supplier Quality Engineer

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.).

Responsibilities:

• 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.

Skills:

• 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.

Qualification And Education:

• 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.

 

Disclaimer: Benefits eligibility, accrual rates, and usage limits may vary based on employment status, length of service, and work location. Paid Sick Leave is provided in strict accordance with applicable state and municipal mandates. Cynet Systems Inc. reserves the right to modify, amend, or terminate any benefit plans at any time in accordance with applicable laws.

About Cynet Systems

Founded in 2010 and headquartered in the Washington, DC metro area, Cynet Systems Inc. is a leading technology staffing and workforce solutions company serving Fortune 500 companies, government agencies, and enterprise organizations across the United States and Canada. We deliver agile, scalable talent solutions across IT, engineering, life sciences, clinical, and professional staffing, powered by a high-performing recruitment engine operating across North America and Asia.

As a nationally and locally certified Minority Business Enterprise (MBE), Cynet Systems is committed to helping organizations build high-performing teams while empowering professionals to grow rewarding careers. Our organization is certified to ISO 9001, ISO 14001, ISO 27001, and SOC 2 Type II standards, reflecting our commitment to quality, security, operational excellence, and customer success.