Senior Quality Engineer
Apply NowCompany: Cynet Systems
Location: Irvine, CA 92620
Description:
Job Description:
Pay Range: $54.18hr - $59.18hr
Responsibilities:
Pay Range: $54.18hr - $59.18hr
Responsibilities:
- Work with new product development teams to help them efficiently navigate the Quality System in order to build quality system test samples and human use product according to project schedules.
- Identify and ensure implementation of opportunities to optimize/improve manufacturing and inspection processes.
- Perform risk assessment on early-stage product manufacturing processes (e.g., PFMEAs, Live Manufacturing Process Reviews).
- Analyze and resolve complex manufacturing and compliance issues (e.g., CAPA, non-conformances, audit observations).
- Develop/drive improvements for inspection test methods.
- Lead test method validation activities for in-process inspections.
- Facilitate and oversee Material Review Board to disposition potentially non-conforming human use products.
- Track product yields and defect rates.
- Use data to report metrics at Quality Data Reviews and drive process improvements.
- Prior experience in medical device manufacturing or operations preferred.
- Experience with computerized Manufacturing Execution System (MES) preferred.
- Bachelor's Degree in a relative Engineering field plus a minimum of four years of medical device industry experience required.
- Master's Degree in a relative Engineering field plus a minimum of three years of medical device industry experience required.
- Strict attention to detail.
- Substantial understanding and knowledge of principles, theories, and concepts relevant to Quality Engineering.
- Strong problem-solving, analytical, and critical thinking skills.
- Exhibits professional communication (e.g., written and verbal) and interpersonal relationship skills, including consultative and relationship management.
- Ability to manage competing priorities in a fast-paced environment.
- Thrives in a collaborative team environment, including inter-departmental teams and key contact representing the organization on contracts or projects.
- Advanced knowledge of statistical techniques and analytics (experience in Minitab preferred).
- Demonstrates strong leadership skills and ability to influence change.
- Knowledge of applicable FDA regulations for the medical device industry.
- Ability to interact professionally with all organizational levels, including Sr Management, cross-functional teams, and external partners.