Senior Quality Engineer (Direct Hire)
Job Requisition: 6463
Description for Sr. Quality Engineer:
Senior Quality Engineer will participate in all aspects of product development, supplier development and manufacturing in order to ensure the highest level of quality in new and existing products, and their compliance to applicable regulations and standards. Sr. QE will apply a passion for detailed analysis to identifying problems and determining the appropriate course of action. He or She will be looked to for communicating quality objectives and building a culture of quality throughout the company.
Responsibilities for Sr. Quality Engineer:
- Represent Quality Engineering on New Product Development (NPD) cross-functional teams, interfacing among multiple departments and teams such as Manufacturing, QC, R&D, Regulatory Affairs, Operations/Planning, and Marketing.
- Review and approve engineering change orders on assigned projects and product lines.
- Plan, design, and implement test methods, including test equipment, for inspection of product.
- Evaluate, update, and improve difficult manufacturing processes and engineering systems for assigned product lines.
- Work with suppliers to continually improve technical processes, reliability, and inspections to meet company quality standards.
- Take the lead on drafting and implementing risk analysis documentation for new and current products with identified hazards and harms.
- Provide leadership and guidance, in the scope of quality systems, to ensure compliance within designated projects and product lines.
- Lead nonconforming report investigations and recommend appropriate corrective actions.
- Identify the need for Corrective Action Preventative Action (CAPA). Initiate, implement and close CAPAs.
- Apply statistical rationale to plan, analyze, and interpret engineering test data collected during new testing.
- Provides leadership and mentoring to more junior staff. May supervise junior engineers.
Requirements for Sr. Quality Engineer:
- Bachelor's degree in Mechanical engineering, Biotechnology, Material Science or related engineering field.
- At least 4 years of process validation and design verification
- A passion for detailed analysis and problem solving.
- A knack for solving mechanical problems effectively.
- The desire to be part of a great team and to represent Quality Engineering on cross-functional technical teams.
- The ability to present issues, plans and objectives in a clear, compelling way, both orally and in writing.
- Versatility, flexibility, and a willingness to work within constantly changing priorities.
- Broad knowledge of applicable regulations and standards, e.g. QSR, ISO 13485.
- Solid knowledge of sterilization, biocompatibility, and transportation and shelf life standards
- Working knowledge of data collection, data analysis, and evaluation, and scientific method.
- R&D or new product development experience is a big plus
- ASQ CQE preferred.