Quality Engineer

About the role

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.

Responsibilities

• 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.
• Ensure 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.
• Provide training as required.
• Perform risk assessments and update risk management documentation as required.
• 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.
• Participate in facility and supplier audits and Notified Body and FDA inspections.

Requirements

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.

Qualifications

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
Exposure to high voltage electronics and radiation

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.