Quality Assurance Engineer II

About the role

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Think differently and challenge what’s possible.

Responsibilities

• Provide Quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System.
• Maintain an accurate log of Non-Conformances and CAPAs activities.
• Facilitate the development, implementation and monitoring of quality programs and policies.
• Collaborate with site NC investigators and CAPA owners from cross-functional areas to facilitate timely and effective closure of all Quality System records.
• Provide hands-on guidance and training to all personnel performing activities within the Quality system.
• Ensure documentation is complete before closure.
• Aid in resolving all product and/or process quality issues.
• Perform Quality and technical review of Nonconformance investigations (NCs) and CAPAs within defined timeframes.
• Ensure investigations and root cause analysis are accurate and complete.
• Prepare monthly and quarterly metrics to present at Quality Review meetings.
• Maintain a thorough understanding of relevant regulations and guidelines.
• Interact and coordinate activities with other departments, external vendors and customers.

Requirements

The Quality Assurance Engineer II will provide Quality compliance support on all aspects of the Plainsboro, NJ CMC Quality System. The role requires 3 to 5+ years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.

Qualifications

• Bachelor’s Degree in Science (Biology, Chemistry) or Engineering (Biomedical, Mechanical, Chemical, or Electrical) preferred.
• Demonstrates knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing.
• Excellent organizational and communication skills.
• Proficient with the MS Office Suite, and statistical software.
• Ability to work independently with minimal supervision.

Skills

Knowledge of investigations, root cause analysis, quality systems, the CAPA system and technical writing.

Benefits

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Pay

$71,300.00 - $97,750.00 USD Salary

Schedule

Not specified