What are the responsibilities and job description for the Quality Engineer position at Entegee?
Contract to possible direct hire
M-F / On-site
Quality Engineer II providing quality engineering support for our Packaging Project including validation activities, documentation, and statistical analysis.
Job Requirements
- Bachelor’s degree in Engineering or related technical discipline
- 2–3 years of experience in quality engineering or manufacturing engineering
- Hands-on experience with process validation (IQ, OQ, PQ)
- Experience performing root cause analysis and supporting CAPA and NCMR activities
- Experience with statistical analysis, including process capability studies (Cp, Cpk, Pp, Ppk)
- Experience with risk assessment tools such as PFMEA
- Experience supporting or executing DR, TMV, and validation quality testing
Preferred Skills
- Experience with packaging validation for medical device or similarly regulated products
- Familiarity with FDA, ISO 13485, or other regulated quality system standards
- Experience creating and maintaining validation protocols and reports
- Experience with data analysis tools and statistical software for validation and process capability
Job Responsibilities
- Provide Quality Engineering support for the Packaging Project from planning through execution and closure
- Lead or support development and execution of process validation activities, including IQ, OQ, PQ, TMV, and associated protocols and reports
- Coordinate and document DR activities related to packaging and associated processes
- Execute and coordinate all validation quality testing and ensure proper documentation and traceability
- Perform root cause analysis for nonconformances and support NCMR and CAPA activities to completion
- Develop, review, and maintain PFMEA and risk assessments for packaging processes and related equipment
- Analyze process and test data to assess process capability and drive validation and process improvement decisions
- Ensure validation and quality records meet internal procedures and regulatory requirements
Equal Opportunity Employer/Veterans/Disabled
Benefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits and 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State or local law; and Holiday pay upon meeting eligibility criteria. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs which are direct hire to a client
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.entegee.com/candidate-privacy-information-statement/
The Company will consider qualified applicants with arrest and conviction records.
Salary : $45 - $53
