Quality Engineer 2

Roles & Responsibilities

Description:

• The Quality Engineer II is responsible for supporting Design Quality Assurance within the Infection Prevention Platform: Design Controls, Risk Management, Human Factors / Usability Engineering.
• The incumbent works cross-functionally with teams on new product design, design transfer, risk management, process/product design, quality improvement projects and change to win (CTW) projects.
• Must be able to work under general direction to exercise judgment within generally defined policies and procedures to select methods and techniques to obtain solutions to problems with broad scope and complexity.
• The incumbent must be able to work closely with business unit and manufacturing plant management as well as other functions (e.g., Regulatory Affairs, Research and Development, Sustaining Engineering, Manufacturing Quality, Operations, Sterility Assurance, Packaging, Sales, Marketing, Finance etc.).
• Reports directly to the Associate Director, Quality for the business unit.
• The incumbent works cross-functionally with business unit management, as well as their respective teams on matters related to new product design, design transfer, risk management, process/product design, and quality improvement projects and plans.

Experience Required

• Minimum 3 years design controls and risk management experience with medical devices. Pharmaceutical knowledge of combination products, preferred.

Skills & Certifications

• Strong knowledge of regulatory requirements (21CFR§4, 21CFR§210&211, 21CFR§820, ISO 13485, CMDR, MDD/EU MDR, and J-PAL).
• Professional certification is an advantage (i.e. CQA, CQE, SQE, CQM, Six Sigma, etc.).
• Attentiveness to details with strong organizational and time management skills.
• Excellent verbal and written communication skills and interpersonal skills.
• Ability to work in a team environment.
• Proficiency in Excel, Word, PowerPoint and other desktop/general business systems.

Eligibilities & qualifications

• Position requires a Bachelor of Science degree in Chemistry or Engineering from an accredited four (4) year university.