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Circuits and Assemblies Quality Assurance Engineer

St. Petersburg, FL 33716

Posted: 04/17/2024 Employment Type: Direct Hire Industry: Engineering Job Number: 5578 Pay Rate: 70,000

Job Description

The Quality Engineer is responsible for ensuring products manufactured by the company conform to approved specifications. Perform thorough validation testing on all newly developed or revised products.

Take a proactive role in conducting root cause analysis to achieve a robust resolution of internal quality issues in current production products. Provide detailed and documented feedback to the company’s suppliers regarding non-conforming materials or Printed Circuit Assemblies (PCAs). Support the Quality

Management System by precipitating in regulatory audits from certification agencies.

1. Conduct comprehensive validation testing for new or updated the company’s products to ensure they align with or surpass the published project scope. Develop a detailed testing plan beforehand, outlining anticipated timeframes for each major testing phase. Utilize provided materials and approach the testing from an end-user perspective.
2. Actively participate in product development meetings as directed and positively contribute to the design process.
3. Present the testing plan to the relevant departments for thorough review. Seek confirmation on testing specifics, methodologies, and ensure a logical approach is established to verify the operational functionality of the product.
4. Review the validation testing plan with the Quality and Regulatory Manager to incorporate supplementary testing to explore potential gaps or limitations in the product's functionality, uncover software bugs, and identify any unconventional operation.
5. Upon completion, provide a comprehensive report including testing results. Provide an executive summary of the results and any suggestions for improvement.
6. Support current production products by participating in root cause analysis of internal quality issues and issues with PCAs received from suppliers. Production support of any internal quality issues from
electrical issues by conducting a thorough investigation and root cause analysis. Initiate and follow thru on any needed internal corrections for controlled documents.
7. Manage the inventory of PCA test fixtures that are provided to the company’s suppliers. Diagnose any reported issues that the supplier has with the performance or operation of the fixtures. Troubleshoot and repair any issues to return the fixture to fully functional status.
8. Manage the internal CAPA system by assisting department process owners in determining root cause and corrective actions to eliminate the problem. Ensure that the investigation, containment, and analytical processes are effectively in place. This includes identifying internal negative trends and overseeing the customer complaint system with effective follow-up practices.
9. Conducts Product Audits to ensure acceptable manufacturing conformance to approved product specifications, work instructions and customer requirements.
10. Conducts training of personnel as required.
11. Designated back-up for QA & RA Manager for Customer, Regulatory and Supplier audits.
12. Designated back-up for QA & RA Manager for Operational and Staff meetings, ECO signature, MRB chair, Timesheets, etc.
13. Performs all other duties as assigned by QA and Regulatory Manager.

1. Approaches jobs and assignments with a well-developed sense of urgency and commitment and communicates this urgency to others.
2. Holds self personally responsible for meeting commitments and getting results.
3. Promotes a culture of high performance and professionalism in accordance with Company core values as reflected in the published culture document of the Company.
4. Proactively identifies, solves, and avoids problems. Encourages others to do the same without criticizing and threatening.
5. Strives for continuous improvement in all areas of responsibility.

--Thorough understanding of electronic circuits and assemblies
--Strong attention to detail. Capability to carry out and follow through with assigned work
--Operate with a sense of urgency.
--Strong analytical and methodical skills.
--Able to prioritize and complete multiple tasks in parallel.
--Ability to make independent and sound judgment based on data.
--Proficient using Windows Office - especially Excel for data analysis.
--Strong follow-through skills.
 --Excellent verbal and written communication skills.
--Working knowledge of ISO 9001 requirements.
--Ability to read engineering drawings and electronic schematics and troubleshoot electronic assemblies to component level.

--Minimum five (5) years of experience in working directly with electronic instrument Product Validation Testing Protocols
--Minimum five (5) years of experience in working with Quality and Regulatory requirements
--Bachelor’s degree in electrical engineering or equivalent required

Respond with your resume or call Margie at 727-687-4103 to discuss the position and schedule an interview.

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