SRG, the leader in the Life Sciences human capital industry, is looking for a Quality Assurance Engineer consultant to join our client's medical device manufacturing team! This position is based in Plainsboro, NJ with a preference for a local candidate who wants to work onsite. However, they will consider remote people as well if it's a great fit and/or for onsite at their other locations in Mansfield, MA or Salt Lake City, UT.

*Onsite: Plainsboro, NJ (remote option considered)

*Contract: 10 months

*W2 contracts only, we cannot accept C2C or 1099 at this time.

The Quality Assurance Engineer - Microbiology provides Quality compliance support for Manufacturing Sites across the network, primarily for Microbiology-related processes and projects within the Sterility Assurance, Endotoxin, and Environmental Controls workstreams.

Qualifications & Skills:

• Education: Bachelor's Degree in engineering preferred (Biomedical, mechanical, chemical, or electrical) or Science (Biology).
• Certifications: ASQ CQE preferred
• Experience: 3 to 5 years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.
• Experience supporting and/or implementing Microbiology-related processes preferred.
• Demonstrates knowledge of statistical sampling and analysis.

Responsibilities:

• Provide Quality compliance support for Microbiology-related processes and projects, including those related to product Sterility Assurance, Endotoxin testing, Environmental Monitoring, Bioburden testing, and other Quality Control Microbiology laboratory testing.
• Providing guidance on the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, manufacturing procedures, product & material specifications, design & development documentation, SOPs, development and task force projects.
• Assists in the implementation of new or improved products/processes, and the transfer of technology from development to commercialization from a Quality and manufacturing perspective.
• Develop, review, and approve Quality documentation including validation protocols/reports and risk assessments.
• Participate in the execution of Process FMEA and other applicable risk analysis documentation as deemed appropriate.
• Develop statistically based sampling plans for in-process and finished goods testing, inspections, validations and wherever required. Provide Statistical Analysis of the data to support the all Quality Systems documentation such as validations, NCs, Complaints, etc.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.