Design and Quality Engineer
3 weeks ago
About Actalent
">At Actalent, we are committed to delivering exceptional results through the power of innovation and collaboration. Our team of expert engineers and scientists works closely with clients to understand their unique challenges and develop tailored solutions that meet their needs.
">Job Description
">We are seeking an experienced Design and Quality Engineer to join our team. As a key member of our design team, you will be responsible for ensuring the quality of our products and systems, identifying and mitigating risks, and collaborating with cross-functional teams to deliver high-quality solutions.
">Responsibilities
">- ">
- Ensure completion of CAPA activities including facilitating root cause analysis and leading cross-functional teams for implementation.">
- Support the Global Quality Management System (QMS) by comprehending its requirements, escalating compliance concerns when needed, and ensuring adherence to regulatory requirements.">
- Ensure compliance with global QMS procedures - design and development, inclusive of design change control.">
- Demonstrate a strong grasp of both agile and waterfall methods of development.">
- Support external QMS inspection and audit.">
Requirements
">- ">
- Minimum 8 years of experience in the industry.">
- Working knowledge of ISO standards (62304, 14971).">
- Bachelor's or Master's degree in Engineering or equivalent education and experience.">
- Ability to implement GMP practices and FDA regulations.">
- Knowledge of product development processes including reliability growth, design quality implementation, design controls, and statistics.">
- Demonstrated skills in technical innovation, technical leadership, and project management.">
- Effective verbal and written communication skills.">
- Proficiency in relevant PC software applications.">
Compensation and Benefits
">The salary range for this position is $130,000.00 - $156,000.00 per year. Additional benefits include medical, dental, and vision insurance, vacation time, paid holidays, sick pay, 401(k), certification reimbursement, and annual raises.
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