Position Title: Quality Engineer
Position Number: 276641
Location: Round Lake, IL
Desired Skill Set:
CAPA, GMP, Quality Assurance, Validation
?Only U.S. Citizens and those authorized to work in the U.S. can be considered as W2 candidates. VALIDATION, QUALITY ASSURANCE, GMP, CAPA?
Sr. Quality Engineer (2 spot)
Duration or End Date: 12months
Location: Round Lake, IL 60073
Contractors will be evaluating complaints to determine if CAPAs are required. We need to move quickly as the HM will be out of town for a conference the week of 2/12.
? Provide Quality Engineeringsupport to manufacturing and product development teams for pharmaceutical products. Provide support for released products, evaluate field returns, and support the incoming inspection department and in-process inspections where required. Support component qualifications and validations to support key development and continuous engineering projects. They will be evaluating complaints to determine if CAPAs are required.
? Provide quality engineeringsupport to manufacturing lines, including floor support, non-conforming product investigations, change order control requests reviews, and new equipment qualifications, and be a factory-focus team member.
? Perform return product investigations for product complaints.
? Monitor manufacturing quality rates and develop reports to communicate performance for manufacturing lines.
? Perform key deliverables in support of development and continuous engineering R&D projects, which may include: mold tool qualifications, component qualifications, design and product risk assessments, shelf life validations, and sterilization validations.
?Work with manufacturing and R&D engineers to prepare work instructions, material specifications, and inspection documentation for new products.
? Set inspection requirements, set inspection methods and inspectionsampling plans.
?Support and test component changes to current products.
?Supportinternal audits and supplier audits.
? Self-motivated worker Strong communication skills
Working knowledge and understanding of mechanical drawings
Strong problem solving, technical writing, and statistical analysis skills
Preferredexperience with supporting a manufacturing product line
B.S. degree in Engineering (prefers Biomedical, Science, or Mechanical, not Electrical)
3-5years in an engineering role within a Medical Device or Pharmaceutical company, 2+ year minimum in Quality Engineering function.
Must have working experience of GMP and ISO13485 requirements.
Software: Advanced Excel (pivot tables, v-lookups, macros, etc), Trackwise (preferred), Word, Outlook
Experience with aseptic technique and filling experience would be strongly preferred. Sitting/standing 8 hours per day.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, arrest and conviction records, or any other characteristic protected by law. Positions located in San Francisco, California will be administered in accordance with the Fair Chance Ordinance.