Seeking a forward-thinking Quality Engineer to join the mission of making life-saving technology accessible to more people. This isn't just a documentation role; it's an opportunity for a technical "game changer" to dive deep into medical device performance and ensure the highest standards of patient safety.
If you have a passion for life and a drive for technical investigation, your next career move starts here in Wayne, NJ.
location: Wayne, New Jersey
job type: Contract
salary: $31 - 32 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Perform engineering investigations of returned products and complaints from the field to determine potential root cause(s) (80%):
- This includes evaluating field-reported information, reviewing applicable risk assessments, instructions for use (IFU), trend data, and other relevant documentation.
- The primary goal is to determine possible failure mechanisms and contributing factors related to the reported issue.
- Document investigation results clearly and accurately in complaint records in accordance with FDA 21 CFR Part 820, ISO 13485, and other relevant standards (15%)
- Collaborate with cross-functional teams (R&D, Manufacturing, Regulatory, Customer Service) to analyze complaint data, trends, and failure modes (5%): The review will include details received from the field for a complaint and the associated investigation activities performed.
- Bachelor's Degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or related technical discipline, or an equivalent combination of education and relevant experience.
- Minimum of 1 year relevant experience which can include internship or co-op experience in the medical device, pharmaceutical, or regulated industry.
- Problem-solving skills and a passion for investigation and root cause analysis.
- Excellent written and verbal communication skills.
- Ability to work in a regulated environment and follow structured procedures.
- Detail-oriented with documentation and organizational skills.
- Proficient in Microsoft Office Suite (Excel, Word, Outlook).Required Knowledge, Skills, and Abilities.
- Internal contacts/relationships with all levels of the organization
qualifications:
- Experience level: Entry Level
- Minimum 1 year of experience
- Education: Bachelors (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.
