Quality Engineer opportunity with a medical device manufacturing client located in the Long Island, NY area. Client is looking for someone ideally with Medical Device or similar experience responsible for all aspects of the Quality Engineering functions to include Process and Product Validations, device reporting assessments and investigations, improving product quality and manufacturing processes and more. This position is bonus eligible.
location: Melville, New York
job type: Permanent
salary: $75,000 - 90,000 per year
work hours: 8am to 4pm
- Medical device reporting assessments and investigations
- Improving product quality and manufacturing processes
- Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development
- Creates reviews and approves Quality System and Product documents
- Create, review, and approve Protocols, Process and Product Validations, Stability Protocols, and Software Validation documents
- Perform Internal or Supplier Quality System Audits
- Perform other duties as assigned
- Bachelor's degree in an engineering/scientific or quality management course of study
- Approximately 5 or more years work experience in Quality Assurance within an FDA, ISO or similarly regulated environment
- Experience in the development and implementation of effective Design Control Systems
- Quality Engineering and Customer Complaint Investigation experience
- Medical Device Industry experience and working knowledge of ISO-13485 preferred Quality management systems, and ISO 14971 Medical devices
- Working knowledge of standards and regulations, including but not limited to US-FDA's 21 CFR Part 820 and 21 CFR Part 803, and GMP
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors
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.
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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).
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