What are the responsibilities and job description for the Quality Engineer position at United Pharma?
Quality Engineer II Biotech Immediate Requirement
Employment Type: W2
We have an immediate opening for a Quality Engineer II to support new product development in a regulated biotech environment.
Key Responsibilities:
Support NPI and ensure quality deliverables across product lifecycle
Apply Design Controls and Risk Management practices
Maintain Design History Files and support product release
Perform FMEA and support design and process verification
Support test method validation and equipment qualification IO PQ
Handle change control, CAPA, deviations, and investigations
Assist with complaint investigations and continuous improvement activities
Required Skills:
Strong experience in Design Controls and Risk Management
Hands on experience with FMEA and validation principles
Experience in New Product Development
Knowledge of ISO standards and regulatory requirements
Experience with biotech hardware and consumables
Basic understanding of cell culture, filtration, and chromatography
Qualifications:
Bachelor’s degree in Engineering or related field
3 to 5 years of Quality Engineering experience in regulated environments
Experience with ISO 9001 or similar QMS
Internal auditing experience preferred
Certification:
ASQ Certified Quality Engineer CQE or Certified Reliability Engineer CRE preferred
Immediate role with quick interview process