Quality Engineer I
SHIFT:
7a-4p or 8a-5p WORK SITE:
Newark (onsite only) INTERVIEW PROCESS:
First Round - Video interview / Second Round - Onsite interview DURATION:
Only approved through the end of December at this time.
Job Summary The Quality Assurance Engineer provides medical device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the manufacture and inspection of medical devices.
The Quality Engineer would work on a range of quality initiatives with regards to the management and improvement of the product, process and supplier quality.
Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
Support new product introductions to ensure the robustness of product builds.
Work in a team environment to develop and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements.
Summary of Duties and
Responsibilities:
- Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
- Requires a bachelor's degree and 0-2 years of experience in the field or in a related area.
- Has knowledge of commonly-used concepts, practices, and procedures within a particular field.
- Relies on instructions and pre-established guidelines to perform the functions of the job.
- Works under immediate supervision.
- Primary job functions do not typically require exercising independent judgment.
Typically reports to a supervisor or manager.
Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Establishes Quality Inspection Reports for Incoming Inspection of newly designed products.
- Aids in the development of Inspection Procedures and Test Methods - Provides Quality Engineering support to existing products - Supports Quality Control with technical input on inspection documentation and with the Material Review Board (MRB) - Investigates and processes Non-Conforming Events.
(NCE).
- Reviews product-related change orders, engineering studies and sustaining engineering projects to assure high quality products and adherence to Quality System requirements.
- Reviews/approves specifications, drawings, manufacturing procedures - Reviews/approves design/process verification and validation documentation - Supports Risk Management activities - Coordinates risk assessments and updates Risk Management documentation as required - Assists Quality at external manufacturing sites on root cause investigations and corrective actions.
Physical Demands The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Sit; use hands to finger, handle or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving and carrying products weighing up to 40 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Chemicals are not actually being used by worker but may be in close proximity to IPA, methanol and acetone.
Safety Shoes with Impact and Compression Protection Must be worn.
Qualifications - Computer literate:
able to use word processing, spreadsheet programs, databases.
- Appetite and desire to perform technical analysis.
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
- Excellent writing skills with ability to write quality assurance reports and detailed procedures.
- Good interpersonal skills to interact with all levels of the company.
- Medical device Quality System Regulations (21CFR820), ISO 13485 and MDD is preferred.
Education - Bachelor's degree (BA or BS) in a technical discipline.
Preferably Electrical, Mechanical or Industrial Engineering.
Recommended Skills Business Requirements Computer Literacy Databases Iso 13485 Industrial Engineering Interpersonal Skills Estimated Salary: $20 to $28 per hour based on qualifications.
7a-4p or 8a-5p WORK SITE:
Newark (onsite only) INTERVIEW PROCESS:
First Round - Video interview / Second Round - Onsite interview DURATION:
Only approved through the end of December at this time.
Job Summary The Quality Assurance Engineer provides medical device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the manufacture and inspection of medical devices.
The Quality Engineer would work on a range of quality initiatives with regards to the management and improvement of the product, process and supplier quality.
Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
Support new product introductions to ensure the robustness of product builds.
Work in a team environment to develop and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvements in meeting all customer requirements.
Summary of Duties and
Responsibilities:
- Performs inspections and sets quality assurance testing models for analysis of raw materials, materials in process, and finished products.
- Requires a bachelor's degree and 0-2 years of experience in the field or in a related area.
- Has knowledge of commonly-used concepts, practices, and procedures within a particular field.
- Relies on instructions and pre-established guidelines to perform the functions of the job.
- Works under immediate supervision.
- Primary job functions do not typically require exercising independent judgment.
Typically reports to a supervisor or manager.
Essential Duties and Responsibilities The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
- Establishes Quality Inspection Reports for Incoming Inspection of newly designed products.
- Aids in the development of Inspection Procedures and Test Methods - Provides Quality Engineering support to existing products - Supports Quality Control with technical input on inspection documentation and with the Material Review Board (MRB) - Investigates and processes Non-Conforming Events.
(NCE).
- Reviews product-related change orders, engineering studies and sustaining engineering projects to assure high quality products and adherence to Quality System requirements.
- Reviews/approves specifications, drawings, manufacturing procedures - Reviews/approves design/process verification and validation documentation - Supports Risk Management activities - Coordinates risk assessments and updates Risk Management documentation as required - Assists Quality at external manufacturing sites on root cause investigations and corrective actions.
Physical Demands The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Sit; use hands to finger, handle or feel objects, tools, or controls.
Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
Lifting/moving and carrying products weighing up to 40 pounds.
Exposure to moving mechanical parts, vibration and/or moderate noise levels.
Exposure to hazardous chemicals or other materials.
Chemicals are not actually being used by worker but may be in close proximity to IPA, methanol and acetone.
Safety Shoes with Impact and Compression Protection Must be worn.
Qualifications - Computer literate:
able to use word processing, spreadsheet programs, databases.
- Appetite and desire to perform technical analysis.
- Excellent ability to read, analyze and interpret professional journals, technical procedures and government regulations.
- Excellent writing skills with ability to write quality assurance reports and detailed procedures.
- Good interpersonal skills to interact with all levels of the company.
- Medical device Quality System Regulations (21CFR820), ISO 13485 and MDD is preferred.
Education - Bachelor's degree (BA or BS) in a technical discipline.
Preferably Electrical, Mechanical or Industrial Engineering.
Recommended Skills Business Requirements Computer Literacy Databases Iso 13485 Industrial Engineering Interpersonal Skills Estimated Salary: $20 to $28 per hour based on qualifications.
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