Join our client, an industry leader in a Hybrid role as a Senior Quality Engineer in Mahwah, NJ, to shape life-changing healthcare! We are seeking a candidate with an Engineering degree, 4+ years of experience, and solid EU-MDR expertise to drive quality compliance. Build life-changing technology and apply today!
location: Mahwah, New Jersey
job type: Contract
salary: $45.16 - 61.00 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Lead quality engineering activities supporting EU-MDR initiatives across a diverse product portfolio to ensure strict regulatory compliance.
- Develop and implement process controls, improvement methods, testing protocols, and inspections to guarantee flaw-free product performance.
- Direct and execute First Article Inspection (FAI) strategies, PPAP, change control assessments, equipment/process validations, and SOP/Risk documentation updates.
- Advocate for and drive initiatives to enhance operational quality performance, applying independent engineering rationale and professional expertise.
- Serve as the cross-functional voice of Quality to maintain compliance with ISO 13485, EU regulations, and QMS standards across multi-site teams.
qualifications:
Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or a related engineering field (required).
4+ years of industry experience with demonstrated expertise supporting EU-MDR programs and initiatives.
Strong knowledge of QMS principles, ISO 13485, GMP/GDP, change management, and risk-based statistical tools, along with exceptional critical thinking and communication 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.
