This is Jahera and I'm a recruiter at Intellectt, Inc. Please find the job description and reach out to me with an updated copy of your resume. You can send it to jahera@intellectt.com or call me at +1(732)-276-2791.
Role: Manufacturing Engineer III
Location: West Valley City, UT - 84119
Duration: 12 Months
Responsibilities
Job Description:
Conduct gap assessments against EUMDR standards.
Generate and execute validation plans and protocols (IQ/OQ/PQ), focusing on Test Method Validation and EUMDR Validation Remediation.
Provide statistical analysis to support validation reports.
Troubleshoot and recommend improvements for equipment/processes during validation runs.
Investigate and document non-conformance incidents and protocol deviations.
Complete Non-Conformance and CAPA investigations.
Collaborate with cross-functional teams including Manufacturing, Engineering, Regulatory, and Quality Assurance.
Ensure compliance with regulatory agencies (FDA, ISO, OSHA, EPA).
Compile and review technical documentation for regulatory submissions.
Participate in external audits (FDA, BSI, Corporate).
Perform additional related duties as needed.
Qualifications
Education: BS in Engineering (Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical) or related sciences.
Certifications: Lean/Six Sigma Green or Black Belt preferred.
Experience: 4-6 years in medical device/pharmaceutical manufacturing environment.
Skills
Strong knowledge of FDA, OSHA, EPA, GMP, and ISO requirements.
Proficient in Organizational Excellence and Lean/Six Sigma.
Strong project management and technical leadership.