What are the responsibilities and job description for the QUALITY ENGINEER position at IFLOWSOFT Solutions Inc.?
Hi,
Greetings from IFlowSoft Solutions Inc
Job Title: Quality Engineer
Location: Sinking Spring, PA
Duration: 36 Months contract
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) with client ALCON
Job Description:
No of years Exp required: Around 5 years
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.
Iflowsoft is an Equal Opportunity Employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, disability, military status, national origin or any other characteristic protected under federal, state, or applicable local law