· A Senior Development Quality Engineer provides ownership of the Design Control deliverables required to support both new product development projects and design change projects
· Accountable for Design Verification and Validation planning & execution, including active cross-functional root-cause analysis investigation & resolution activities
· Lead Risk Management activities from product Concept through Commercialization
· Support design test and inspection method development, and lead method validation activities
· Ensure DHF content integrity, completeness, and regulatory / standards compliance; collaboratively communicating & resolving gaps
· Detailed knowledge of FDA, GMP, and ISO 13485
· Solid communication and interpersonal skills
· Project management and leadership skills, including the demonstrated ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner
· Advanced computer skills, including statistical/data analysis and report writing skills
· Prior medical device experience preferred
· ASQ CQE certification preferred
· Design for Six Sigma and Critical to Quality training and experience preferred
About The Fountain Group:
Headquartered in Tampa, FL, with operations in all 5 regions, The Fountain Group is a Contingent Labor Resource Provider. The Fountain Group services clients directly, clients with an internal contingent labor program, and clients with an external managed service program.
At The Fountain Group, we know that searching for a new career can be stressful, which is why we take time to understand your skills and personal goals. We understand the importance of job flexibility and professional growth, and offer top-notch positions with leading employers. In fact, the majority of our clients are well known Fortune 100-500 companies. We also offer a variety of benefits to our associates to ensure their overall happiness.
In addition to assisting with your job search, we will help you through every step of the process offering online tutorials and additional resources to enhance your industry knowledge and skills. As your employment agent, we are dedicated to providing career counseling and job advice, knowing precisely what established companies want.
At The Fountain Group, we treat you like family, regardless of your proximity to our office. We are dedicated to providing you with an exciting, challenging and highly rewarding place to work. Become a part of our team today and let us put your talents to work.
If you are interested in hearing more about the position please respond to this email with a copy of your resume in word form with the best contact info Please forward this email to any friends or colleagues
Role: Senior Development Quality Engineer
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