Quality Engineer
Aspen Surgical · Jamaica, NY · 3 mo ago
On-siteEngineeringFull-time
Qualifications
- Bachelor’s Degree in Engineering preferred, or a related technical discipline such as, Chemistry or Biology.
- A minimum of 3–5 years of quality engineering experience in a medical device, pharmaceutical, or regulated manufacturing environment.
- ASQ certification a plus (CQE, CQA).
- Experience in chemical mixing, liquid formulation, or filling operations preferred.
Skills
- Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels.
- Able to make effective decisions and maintain effectiveness under changing circumstances and priorities.
- Teamwork, communication, positive attitude required to support the manufacturing environment.
- Problem Solving – able to perform root cause analysis and implement effective corrective actions.
- Able to effectively manage and complete multiple projects simultaneously.
- Excellent computer skills including but not limited to Microsoft Office Suite.
- Knowledge of quality systems including the quality manual, quality policy and applicable procedures and work instructions.
- Ability to support the establishment, implementation, and maintenance of the quality system in accordance to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.