Our client is seeking a Principal Quality Engineer to lead the development and maintenance of quality engineering policies for life-saving medical technology. As the Principal Quality Engineer, you will ensure design integrity conforms to global standards while managing critical risk files and health hazard evaluations. This leadership role is vital in driving quality excellence and regulatory compliance across the product lifecycle.
location: Wayne, New Jersey
job type: Permanent
salary: $140,000 - 165,000 per year
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Lead and maintain Quality Management System procedures, focusing on Design Controls, Risk Management, and Field Action Plans.
- Coordinate with R&D and Manufacturing teams to ensure design quality and accuracy for both new and sustaining product development.
- Manage product Risk Files and lead Health Hazard Evaluations (HHEs) to assess performance risks and inform field action decisions.
- Provide quality oversight for software validation, including embedded systems and SaMD, while supporting internal and external audits.
- Drive Failure Modes and Effects Analysis (FMEA) sessions and lead root cause investigations for nonconformances and CAPAs
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qualifications:
- Experience level: Manager
- Minimum 7 years of experience
- Education: Bachelors (required)
skills:
- Quality (7 years of experience is preferred)
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.
