Product Quality Engineer
A Product Quality Engineer is needed for an American medical technology company primarily focused on women's health, selling medical devices for diagnositcs, surgery, and medical imaging, in the Marlborough, MA area. This role requires a degree in biomedical or mechanical engineering and at least 1 year of experience in a regulated industry to manage medical device risk assessments and complaint trend analysis while ensuring compliance with ISO 14971 and 21 CFR 820 standards. location: Marlborough, Massachusetts
job type: Contract
salary: $50.72 - 70.00 per hour
work hours: 8am to 4pm
education: Bachelors responsibilities:
- Analyze complaint information to identify reported hazardous situations and harms.
- Evaluate content in existing Risk Management Files to ensure all reported situations are captured.
- Perform trend analysis using Statistical Process Controls per established quality procedures.
- Execute other function-related activities as reasonably required by business needs.
- Possess a Bachelor of Science in biomedical engineering, mechanical engineering, or a health care related discipline.
- Have a minimum of 1 year of experience working with medical devices or another highly regulated industry.
- Maintain a background in Quality Engineering as a preferred qualification.
- Hold experience in authoring and executing risk assessments as a preferred qualification.
- Maintain experience with Quality System Regulations including ISO 13485 and 21 CFR 820.
- Demonstrate experience with ISO 14971 Risk Management standards.
- Possess basic knowledge of risk analysis techniques such as FMEAs.
- Apply basic knowledge of medical terminology and anatomy.
- Utilize basic knowledge of engineering and process terminology.
- Understand statistics including Statistical Process Control with a preference for Minitab experience.
- Maintain working knowledge of 21 CFR 803 and 21 CFR 820.
- Demonstrate a detail-oriented approach to maintaining accuracy and compliance.
- Show reliability and accountability with a focus on timely communication and issue escalation.
- Act as a collaborative team player open to receiving feedback and contributing to shared goals.
- Work effectively on project teams and take leadership roles on critical tasks.
- Assess written product and project documentation effectively.
- Communicate technical assessments clearly and efficiently.
- Experience level: Experienced
- Education: Bachelors
skills:
- Quality
- Medical Device
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 [email protected].
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. It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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