We are seeking a dedicated Quality Complaint Investigation Engineer to join our team. In this role, you will lead comprehensive investigations into product complaints, ensuring compliance with regulatory standards and driving continuous improvement initiatives. Your analytical skills and attention to detail will be essential in identifying root causes and implementing effective corrective actions.
location: Skaneateles Falls, New York
job type: Contract
salary: $28 - 30 per hour
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Lead comprehensive investigations into product complaints, analyzing service data to determine risk levels and root causes.
- Analyze data from various quality inputs, such as Field Corrective Actions (FCA), complaints, and FDA Medical Device Reports (MDR), to identify trends and systemic issues.
- Develop and communicate expectations for quality performance, continuous improvement, and process controls for marketed products.
- Monitor and drive corrective actions and continuous improvement activities by performing primary investigations, conducting data analysis, and implementing corrective actions.
- Support Corrective and Preventive Actions (CAPA) and maintenance activities for existing product lines.
- Bachelor of Science degree in Engineering.
- 1-3 years of experience in the medical device industry.
- Knowledge of 21 CFR 820 and FDA cGMP regulations.
- Experience with statistical software packages (Minitab is a plus).
- solid analytical problem-solving skills and the ability to conduct root cause investigations.
- Investigative research and data analysis.
- Proficiency in reading and understanding blueprints and technical drawings.
- Computer competency in Word, Excel, PowerPoint, Minitab, Access, and databases.
- Ability to multi-task and methodically manage projects.
qualifications:
- Experience level: Experienced
- Minimum 3 years 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 health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
