Step into a high-impact role driving global product transfers and new production line setups for medical devices and combination products. You will lead design reviews, execute hands-on process validations, and oversee critical transfers into Costa Rica while keeping projects on schedule and fully compliant. Operating from a modern, state-of-the-art facility equipped with advanced manufacturing infrastructure and modern laboratory environments, this position balances hands-on technical execution with cross-functional leadership.
location: Waukegan, Illinois
job type: Contract
salary: $55.00 - 69.15 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Manage project schedules hands-on, leading design, verification, and project reviews.
- Oversee capital equipment and design transfers into Costa Rica, including setting up new production lines.
- Drive and execute hands-on medical design and process validations.
- Review and approve design verification and transfer protocols within the Quality Operations department.
- Ensure validation and qualification strategies for equipment, processes, and utilities meet cGMP regulations.
- Provide technical direction for quality engineering matters across manufacturing, tech transfer, and market expansion projects.
- Guide quality risk management activities, including risk assessments and mitigation planning.
qualifications:
Required Skills
- BS/MS degree in Engineering, Physical, or Life Sciences.
- 5+ years of combined Quality Engineering and Project Management experience in medical devices/combination products.
- Hands-on experience managing global product/design transfers and setting up new manufacturing lines.
- Direct experience executing hands-on process, equipment, and facility validation and qualification protocols.
- Strong working knowledge of cGMP regulations, Quality Systems, statistical quality systems, and risk management.
- Proven ability to present and communicate effectively across cross-functional teams.
- Certified Project Manager (CPM) or Certified Quality Engineer (CQE) certification.
- Advanced degree (Master's or PhD) in Engineering or Life Sciences.
skills: Project Management, MS-Project, Quality Assurance (QA), Quality Control (QC)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
