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Prin Quality Eng.

US Tech Solutions, Inc

This is a Contract position in Franklin Lakes, NJ posted June 20, 2020.

Job Description

US Tech Solutions is seeking a “Prin Quality Eng.” for a 6+ Months (Possible extension) contract position with a client in Franklin lakes, NJ

Job Overview
Individual with thorough experience in quality engineering, quality systems, validation, risk management and design control for a market leader in the medical device industry.


Summary of Skills
• Extensive knowledge of quality engineering, and or quality systems for medical devices
• In-depth knowledge of the concepts of; design control, engineering change control, statistical techniques, verification and validation methods/protocols, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k), complaint handling etc.
• Well-versed in the methodologies of verification and validation for medical devices
• Sound knowledge of FDA Quality System Regulations; 21 CFR Part 210, 211, especially 21 CFR Part 820 and 21 CFR 820.198 etc. Knowledge of the European Medical Device (MDR) regulations a plus
• Sound knowledge of ISO13485 for medical devices
• Quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc.
• Audit experience a plus
• Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP and Trackwise systems a plus
• Can communicate effectively
• Must be able to work under minimal supervision on somewhat ambiguous tasks

Work Experience
• Medical Device Quality Engineer/Quality Systems Engineer/Quality Auditor
• About five (5) plus years of experience within FDA regulated medical device and or pharmaceutical industry with knowledge of FDA and ISO regulations

Education and Certifications
• Bachelor’s Degree in a scientific discipline
• ASQ CQE, CQA, Six Sigma certification a plus
Additional Job Description
• Assist in special assignment to assess FDA regulatory gap analyses
• Assist in special assignment to assess compliance to the new European MDR requirements

About US Tech Solutions:

Your talent, our opportunities – This is the premise behind US Tech Solutions.

You have the skill we have the opportunity. As a team, we work passionately for you to get the right career opportunity across industry verticals and functions. For past sixteen years, leading Global

Companies and Fortune 500 come to us to get the right talent. Whether you want to work as full-time, contractor or part-time, technical or non-technical our talent consultants will connect with the right career opportunity globally.

Connect with our talent team today.

USTECH was founded in 2000 by Manoj Agarwal. Today, we are a global firm offering talent solutions to 150 customers including 20% of Fortune 500 across Financial Services, Healthcare, Life Sciences, Aerospace, Energy, Retail, Telecom, Technology, Manufacturing, and Engineering. We are headquartered in New Jersey with 40 global locations across the USA, Canada, Europe, and India. Deloitte has recognized USTECH as one of the fastest growing private businesses for the past five consecutive years and INC 500 for the past three. We have also been rated “The Top Business in the US” by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website: www.ustechsolutions.com.

“US Tech is an Equal Opportunity Employer” and “US Citizens & all other parties authorized to work in the US are encouraged to apply.”

Apply: Interested candidates are requested to send their resume to Dharmendra at [email protected]

Job Requirements:

Job Description

US Tech Solutions is seeking a “Prin Quality Eng.” for a 6+ Months (Possible extension) contract position with a client in Franklin lakes, NJ

Job Overview
Individual with thorough experience in quality engineering, quality systems, validation, risk management and design control for a market leader in the medical device industry.


Summary of Skills
• Extensive knowledge of quality engineering, and or quality systems for medical devices
• In-depth knowledge of the concepts of; design control, engineering change control, statistical techniques, verification and validation methods/protocols, risk management, design history files (DHF), device history and master records (DHR/DMR), CAPA, 510(k), complaint handling etc.
• Well-versed in the methodologies of verification and validation for medical devices
• Sound knowledge of FDA Quality System Regulations; 21 CFR Part 210, 211, especially 21 CFR Part 820 and 21 CFR 820.198 etc. Knowledge of the European Medical Device (MDR) regulations a plus
• Sound knowledge of ISO13485 for medical devices
• Quality engineering concepts such as; statistical analysis, measurement and calibration systems, quality testing, sampling and inspection, process control, SOPs, engineering change notices etc.
• Audit experience a plus
• Knowledge of basic computer applications, Microsoft suite of tools (Word, Excel, Power Point etc.), Minitab for statistical analysis, SAP and Trackwise systems a plus
• Can communicate effectively
• Must be able to work under minimal supervision on somewhat ambiguous tasks

Work Experience
• Medical Device Quality Engineer/Quality Systems Engineer/Quality Auditor
• About five (5) plus years of experience within FDA regulated medical device and or pharmaceutical industry with knowledge of FDA and ISO regulations

Education and Certifications
• Bachelor’s Degree in a scientific discipline
• ASQ CQE, CQA, Six Sigma certification a plus
Additional Job Description
• Assist in special assignment to assess FDA regulatory gap analyses
• Assist in special assignment to assess compliance to the new European MDR requirements

About US Tech Solutions:

Your talent, our opportunities – This is the premise behind US Tech Solutions.

You have the skill we have the opportunity. As a team, we work passionately for you to get the right career opportunity across industry verticals and functions. For past sixteen years, leading Global

Companies and Fortune 500 come to us to get the right talent. Whether you want to work as full-time, contractor or part-time, technical or non-technical our talent consultants will connect with the right career opportunity globally.

Connect with our talent team today.

USTECH was founded in 2000 by Manoj Agarwal. Today, we are a global firm offering talent solutions to 150 customers including 20% of Fortune 500 across Financial Services, Healthcare, Life Sciences, Aerospace, Energy, Retail, Telecom, Technology, Manufacturing, and Engineering. We are headquartered in New Jersey with 40 global locations across the USA, Canada, Europe, and India. Deloitte has recognized USTECH as one of the fastest growing private businesses for the past five consecutive years and INC 500 for the past three. We have also been rated “The Top Business in the US” by Diversity Business since 2011. To learn more about how US Tech Solutions visit our website: www.ustechsolutions.com.

“US Tech is an Equal Opportunity Employer” and “US Citizens & all other parties authorized to work in the US are encouraged to apply.”

Apply: Interested candidates are requested to send their resume to Dharmendra at [email protected]