Quality Engineer

job summary:
Are you an ambitious engineer looking to accelerate your career in medical device compliance? A leading global healthcare manufacturing organization is seeking a detail-oriented Quality Engineer for a fully onsite role. This position offers unparalleled mentorship under senior engineering leadership while working on high-priority supplier quality and QMS remediation initiatives ahead of major regulatory inspections.

location: Warrendale, Pennsylvania
job type: Contract
salary: $75.00 - 82.76 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Manage compliance documentation for approximately 200 suppliers, owning the outreach, tracking, and final file approval processes.
• Remediate QMS gaps against 21 CFR Part 820 and MDSAP by collaborating with Principal Engineers to author and update procedures.
• Navigate internal Document Control Systems to route QMS technical writing changes for regulatory approval.
• Assist with CAPA (Corrective and Preventive Action) remediation by reviewing and categorizing existing files by risk level.
• Develop regulatory compliance "storyboards" for critical CAPAs to ensure audit readiness for upcoming FDA inspections.

 
qualifications:
Required:

• Bachelor's degree in Engineering or a related technical discipline
• 1-3 years of quality engineering experience within a highly regulated manufacturing industry (Medical Device, Pharma, Aerospace, or Automotive)
• Hands-on experience with QMS documentation and SOP technical writingFunctional understanding of CAPA processes, risk categorization, or remediation.
• Ability to work fully onsite

#LI-CV1

skills: MS-EXCEL, Corrective and Preventive Actions (CAPA), Quality Assurance (QA)


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 View email address on 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.

Any consideration of a background check would be an individualized assessment based on the applicant or employee's specific record and the duties and requirements of the specific job.