Quality Engineer

Quality Engineer II

Location: Newark, DE

Onsite Flexibility: Onsite

Contract Details

• Position Type: Contract
• Contract Duration: 12 months
• Pay Rate: $55.00 / Hour (USD)
• Shift / Schedule: 2nd Shift, 2:00 PM - 10:30 PM; 1 Saturday expected per month (OT)
• Work Authorization: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Job Summary

Designs, implements, and maintains quality assurance protocols and methods for processing materials into partially finished or finished products. Responsible for planning, implementing, and managing compliance of manufacturing and production processes with internal and external safety, quality, and regulatory standards requirements for worldwide distribution. Designs methods and procedures for inspecting, testing, and evaluating the precision and accuracy of production processes, production equipment, and finished products. Performs analysis of reports and production data to identify trends and recommend updates or changes to quality standards and procedures when necessary. May ensure compliance to in-house and/or external specifications and standards (i.e., GLP, GMP, ISO, Six Sigma).

Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action. Builds productive internal/external working relationships.

Developing professional expertise, applies company policies and procedures to resolve a variety of issues. Normally receives general instructions on routine work, detailed instructions on new projects or assignments.

Key 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.

• Write & Execute TMV's and Simple Change Orders (Simple Procedure updates, no validations required, clarifications, etc.)
• Support Moderate to Complex Project Change Orders (validations, risk analysis updates, creation or major changes of SOP's/documents, etc.)
• Write & Execute PQ's
• Lead/Own CAPA's
• Support HRA's/HHE's
• Model all quality values and coach others on BSH quality system requirements and standards to elevate the team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste, and provide for continuous improvement.
• Provide quality engineering support to Operations, Engineering, and R&D in the design and manufacture of medical devices to ensure robust product builds and the production of high-quality products and manufacturing practices.
• Responsible for ensuring that the products produced meet applicable regulatory and quality standards and customer expectations.
• Develop and implement procedures, inspection procedures, and test methods in compliance with QMS, Medical Device Quality System Regulation, and Medical Device Directive requirements. Provides training as required.
• Act with urgency to identify and provide timely resolution to quality issues. Perform risk assessments and update risk management documentation as required.
• Perform customer complaint investigations, root cause investigations, root cause analysis, problem solving, and corrective actions.
• Review technical publications, articles, and abstracts to stay abreast of technical developments in the industry.
• Investigate and process Quality System Investigations (QSI) and Non-Conforming Events (NCE).
• Prepare reports assessing the suitability and effectiveness of assigned areas of the quality system.
• Actively participate in processes and meetings such as MRB, NCE, CAPA, and SCAR process.
• Review and approve routine to moderately complex ECO's, product-related change orders, engineering studies, sustaining engineering products, specifications, drawings, manufacturing procedures, design process verification, and validation documentation.
• Actively participate in facility and supplier audits and Notified Body and FDA inspections.

Required Skills

• Excellent computer skills including ability to use word processing, spreadsheet programs, and databases
• Excellent ability to read, analyze, and interpret professional journals, technical procedures, and government regulations
• Excellent technical writing skills with ability to write quality assurance reports and detailed procedures
• Good presentation skills
• Good interpersonal skills to interact with all levels of the company, sometimes in an adversarial role
• Knowledge of GMP and GDP Principles

Preferred Skills

• Working knowledge of medical device Quality System Regulations (21CFR820), ISO 13485, and MDD requirements is beneficial
• Knowledge of microbiology, molecular biology, biochemistry, chemistry, and/or related disciplines is beneficial
• Understanding of nucleic acid amplification and detection technologies is beneficial
• Understanding of Scientific Method and statistical analysis is beneficial
• Knowledge of Oracle and Agile is beneficial
• Certified Quality Engineer is beneficial
• Experience in an FDA regulated industry is beneficial

Education Requirements

• Preferred Minimum: Technical Bachelor's Degree
• 1-2 years of experience with a Technical Bachelor's Degree; 0-2 years with a Master's Degree

Required Experience

• 1-2 years of experience with a Technical Bachelor's Degree, or 0-2 years with a Master's Degree

Work Environment / Physical Requirements

• 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
• Safety Shoes with Impact and Compression Protection must be worn in designated areas
• Exposure to blood
• Ability to work in a clean room, controlled environment, and/or dark room
• Exposure to high voltage electronics and radiation

Important Notes

• Interview Process: Initial 30-minute MS Teams call with Hiring Manager; 2nd Round Onsite Meeting with Hiring Manager & Skip Level

Benefits

• Medical, Vision, and Dental Insurance Plans
• 401k Retirement Fund

About the Client

This client operates in the medical device manufacturing industry, designing and producing diagnostic and treatment technology - including women's health applications - for worldwide distribution from their Newark, DE facility. The organization functions within an FDA-regulated environment with rigorous GMP and GDP compliance requirements, and employs quality assurance engineers, manufacturing technicians, receiving inspectors, and related technical professionals who collaborate across operations, engineering, and R&D functions.

About GTT

GTT is a minority-owned staffing firm and a subsidiary of Chenega Corporation, a Native American-owned company in Alaska. We highly value diverse and inclusive workplaces and support Fortune 500 organizations across banking, financial services, technology, life sciences, biotech, utilities, and retail sectors throughout the U.S. and Canada.

Job Number: 26-08562 Industry: Manufacturing & Operations

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