Job ID: 3184268
Fulltime Onsite Opportunity with Paid Relocation
Quality Engineer II (Hybrid) – Franklin Lakes, New Jersey
Industry: Medical Equipment / Devices
Job Category: Manufacturing – Quality
Our client, a leading medical technology company with many Award-Winning Clients all over, is seeking a talented individual for the position of Quality Engineer II in Franklin Lakes, New Jersey.
- Evaluate customer requirements to identify applicable quality standards
- Serve as a key team member
- Release product during development activities
- Realize quality functional reviews
- Ensure implementation of global procedures and standards for QE engineering activities
- Provide support to internal, regulatory body, and customer audits, along with associated corrective actions.
- Assist/conduct Failure Investigations and problem-solving sessions for non-conforming products
- Consistently apply technical principles, theories, concepts, and quality sciences/tools
- Review and have Quality Engineering approval authority for new and modified design/process specifications
- Contribute to the completion of specific programs and projects
- Ensure quality conduct of projects, including design, data summary and interpretation, and report generation
- Independently determine and develop an approach to a solution
- Provide guidance and work direction to other team members
- Design and perform development working independently within defined parameters
- Liaise with Manufacturing Plants
- Provide functional support to cross-functional teams
- Define product control strategy
- Lead risk management activities
- Ensure design control elements are satisfied
- Ensure/perform process validation activities
- Develop/perform supplier qualification plans
- Evaluate test methods used in project activities
- Develop systems, processes, and procedures related to project quality activities.
- Support continuous improvement of current products and practices
- Ensure the terms of the agreement are met
- Support customer-facing teams by providing technical support from a quality perspective.
- Share risk mitigation strategies and control plans for the device with customers as applicable.
- Education: BS degree in Engineering or another scientific field
- Experience: Quality Engineering experience or 12+ years industry experience (Medical Device/Pharmaceutical)
- Special Skills:
- Thorough understanding of industry regulations/standards: ISO 13485, QSR, GMP
- Knowledge of design control principles.
- Thorough understanding of statistical methods for Quality Assurance
- Experience in Quality System, Six Sigma Methodology, Validation, FMEA/Risk Management.
- Knowledge and experience in manufacturing, project management, and engineering.
- Good written and oral communication skills
- Excellent problem-solving and analytical skills
- Must possess excellent oral and written communication skills, and supervisory/leadership capability.
- Ability to handle multiple projects simultaneously in an unsupervised environment.
Job ID: 3184268