Location : Monroe NY US 10950
Job Type : Direct
Reference Code : 20693-BZ1
Compensation : 85000.00 - 100000.00 USD/YEAR
Start Date : 08/24/2021
Hours : Full Time
Required Years of Experience : 2
Required Education : BS Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices
Job Description :
- Permanent position for a Quality Engineer to provide support to both new product development and continuous improvement initiatives for existing medical device product lines.
- Use statistical analysis, test method development, engineering principals, and awareness of relevant procedural and regulatory requirements to move projects and initiatives to successful completion.
- Identify applicable quality standards and appropriate test methods for the assessment of product and/or process performance.
- Implement Design Control during the launch of new products and significant product design changes.
- Review designs, design changes, validation plans, and specification changes and makes recommendations relevant to compliance, risk, and performance.
- Track and review corrective and preventive actions (CAPA’s).
- Document non-standard and nonconforming processes or product and then work with other engineers and departments to find a solution and disposition.
- Perform experiments, applying accepted design of experiment techniques.
- Author and execute test method and process validations.
- Develop sampling plans by applying attribute, variable, and sequential sampling methods.
- Analyze data by completing hypothesis testing, 2 sample t-tests, and process capability analyses.
- Prepare reports by collecting, analyzing, and summarizing data; making recommendations.
Required Qualifications :
- BS Engineering or other technical discipline
- Proven record of test method development, execution of validations, and data-based decision making.
- Minimum 2-5 years of work experience in a similar role, ex. laboratory testing, documentation of test reports and test protocols, prototyping, or commercialization.
- Self-starter and comfortable being a subject matter expert within the company.
- Experience in the medical device field a plus.
Contact: Bill Zukowsky