Quality Engineer II

Position Title:

Quality Engineer II Work Location:

Newark

DE 19702

Assignment Duration:

6 Months (Pending confirmation)

Work Schedule:

2nd shift: 2pm-10:30pm; 1 Saturday per month expected (OT)

Work Arrangement:

100% onsite

Position 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.

Background & Context:

Supports quality engineering for the design and manufacture of medical devices to ensure robust product builds, high-quality manufacturing practices, and compliance with applicable regulatory and quality standards.

Key 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 coaches others on BSH quality system requirements and standards to elevate 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.
• Develops and implements procedures, inspection procedures and test methods in compliance with QMS, Medical Device Quality System Regulation and Medical Device Directive requirements. Provides training as required.
• Acts 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.
• Reviews technical publications, articles and abstracts to stay abreast of technical developments in the industry.
• Investigates and processes Quality System Investigations (QSI) and Non-Conforming Events (NCE).
• Prepares reports assessing the suitability and effectiveness of assigned areas of the quality system.
• Active participation 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.
• Active participant in facility and supplier audits and Notified Body and FDA inspections.

Qualification & Experience:

Preferred Minimum Technical/Advanced Degree:

Technical Bachelor's Degree

Preferred Minimum Experience:

1-2 Years with Technical Bachelor's Degree, 0-2 Years with Master's Degree

• Experience in an FDA regulated industry is beneficial.
• 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 details procedures
• Good presentation skills
• Good interpersonal skills to interact with all levels of the company, sometimes in an adversary role
• Knowledge of GMP and GDP Principles
• 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.

Working Conditions & Physical Demands:

• 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.

Other:

high voltage electronics, radiation. Ability to work in clean room, controlled environment, and/or dark room.

Additional Information:

The incumbent may be aske