Elevate MedTech with Our Client! Hiring a Senior Quality Engineer at Mahwah , NJ. Requires a BS in Engineering, 4+ yrs experience, and QMS/validation expertise to drive compliance and process control for life-saving devices. Join an industry leader shaping global healthcare!
location: Mahwah, New Jersey
job type: Contract
salary: $52 - 61 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Develop and implement process control, inspection, and testing procedures to eliminate product flaws and ensure optimal device functionality.
- Lead key quality assurance activities, including First Article Inspection (FAI) strategies, PPAP execution, equipment and process validations, and risk management reviews.
- Manage change control processes, conduct change impact assessments, and update QMS and SOP documentation.
- Serve as the voice of Quality across cross-functional teams, driving compliance with industry regulations and standards.
- Operate independently as a senior individual contributor, exercising sound engineering rationale to resolve technical quality challenges.
qualifications:
Bachelor's degree in Biomedical, Mechanical, or a related Engineering field with 4+ years of industry experience required.
Demonstrated expertise in engineering validation processes, Quality Management Systems (QMS), and independent technical decision-making.
Strong working knowledge of medical device concepts and regulatory frameworks (such as ISO 13485, EU-MDR, GDP, and GMP) alongside excellent 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.
