Quality Engineer

Hi,

Greetings from IFlowSoft Solutions Inc

Job Title: Quality Engineer
Location: Sinking Spring, PA
Duration: 36 Months contract
Experience : 6+ yrs

Interview: Initial Video Screen with vendor and 2 rounds of Interview ( 1st interview through (phone or video) and

2nd final interview -Need to go F2F)


Job Description:

Leading Medical Device/ Pharmaceutical company is seeking an experienced Quality Engineer in a GMP-regulated facility. This is a three-year project within the engineering group primarily supporting quality intelligence Engineering and investigations. You will be working with several departments and must be a critical thinker able to work independently. Good communication skills are very important.

Key Responsibilities:

• Ensure compliance with current Good Manufacturing Practice (cGMP), Health Authority, Alcon Quality Manual requirements, and International Organization for Standardization (ISO) standards.
• Work with the Quality and Manufacturing teams to support activities during the overall product life cycle of the assigned production area(s).
• Investigate and/or provide input on non-conformance events (NC) and Corrective Actions and Preventive Actions (CAPA).
• Perform quality approval on SOP''s, specifications, preventative maintenance, calibration, and training documents.
• Utilize quality principles and tools.
• Provide QE support for process validations.
• Manage product holds and quarantine and support escalation events.
• Lead, support and promote improvement activities for the site.
• Oversee the site’s change control program, ensuring all changes follow established quality and compliance requirements.

Requirements for Quality Engineer:
• Engineering degree preferred.
• Previous Quality engineering experience preferably with medical device manufacturing companies and/ or pharmaceutical manufacturing companies.
• Familiar with Quality Management Systems such as Siemen Team Center and Veeva.
• Familiar with enterprise systems such as SAP.