Join an industry-leading advanced manufacturing company in Ormond Beach, FL, dedicated to engineering mission-critical controlled environments. Our client designs and builds custom mobile and modular cGMP cleanrooms, biocontainment laboratories, and pharmaceutical equipment that directly support life-saving research, biotech innovation, and global health security worldwide. In this role, you will apply your quality engineering expertise to complex, highly regulated technologies while enjoying a permanent 4x10 schedule (four 10-hour shifts), giving you a guaranteed three-day weekend every week to recharge.
location: ORMOND BEACH, Florida
job type: Permanent
salary: $70,000 - 85,000 per year
work hours: 8am to 4pm
education: No Degree Required
responsibilities:
- Execute and maintain the ISO 9001:2015 Quality Management System (QMS), ensuring compliance across fabrication, assembly, and final acceptance.
- Investigate nonconformances using methodologies like 8D and 5-Why, and manage the MRB and CAPA processes to closure.
- Develop Control Plans, PFMEAs, and critical-to-quality (CTQ) parameters while performing First Article Inspections (FAI) for advanced custom-manufactured environments.
- Apply industry standards (cGMP, FDA 21 CFR, ISO 14644, EU GMP) directly to mission-critical products to meet strict customer validation requirements.
- Collaborate with engineering and production floors, utilizing Lean Six Sigma tools (DMAIC, Kaizen, 5S) to reduce defects, scrap, and cycle times.
- Bachelor's degree in Mechanical, Manufacturing, Industrial, Chemical Engineering, or a related technical discipline (or equivalent practical experience).
- 3-6 years of hands-on quality engineering experience in a manufacturing setting, ideally working with custom-fabricated and integrated systems (HVAC, structural, electrical).
- Direct experience in highly regulated, precision-manufacturing environments (such as Medical Device/ISO 13485, Pharma/cGMP, or Aerospace/AS9100) is strongly preferred
- Proficiency with core quality tools including FMEA, Control Plans, SPC, APQP, and CAPA, as well as the ability to read engineering drawings, GD&T, and weld symbols.
- ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or Lean Six Sigma Green/Black Belt certification, a plus
qualifications:
- Experience level: Experienced
- Minimum 4 years of experience
- Education: No Degree Required
skills:
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.
