The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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CoapTech is an exciting and growing medical device company in Baltimore. We are looking to hire a talented Quality Engineer professional to join our team. This person will also serve as the company’s Quality Manager. If you are looking for an exciting opportunity to work and grow with a leading medical device start-up, CoapTech is a great place to expand your career. Please reach out for additional information.
Responsibilities for Quality Engineer / Quality Manager
Set detailed guidelines on what needs to be checked and what the quality standards are
Update our Quality Management System (QMS) as needed
Lead audits and inspections of our systems based on ISO 13485:2016 and 21 CFR 820 requirements
Develop inspection methods to analyze product quality
Ensure products adhere to company and industry quality standards
Brainstorm ideas to create solutions for identified problems
Document results and findings after inspections are carried out
Determine quality metrics for manufacturing and quality procedures
Monitor the entire production cycle and perform regular tests to identify potential malfunctions as early as possible
Identify the root of technical issues and recommend fixes
Prepare reports on malfunctions and corrective actions
Review current drawings and quality documentation
Set and track quality assurance goals
Coordinate with external quality assurance auditors and technicians to ensure legal compliance
Work with internal teams to increase customer satisfaction by improving the quality of the products
Qualifications for Quality Engineer / Quality Manager
Previous work experience as a Quality Engineer or similar role
Hands-on experience with Quality Management Systems (QMS) and testing methodologies
In-depth understanding of technical documentation
Familiarity with statistical analysis
Great attention to detail and problem-solving abilities
Team spirit, able to work efficiently in a team environment
Good analytical skills
Excellent verbal and written communication skills
BSc in Mechanical Engineering, Industrial Engineering or relevant field
Additional certification in Quality Assurance or Quality Management Systems is a plus
Additional Salary Information: Compensation package includes potential for equity
Internal Number: 100712
CoapTech seeks to bring a series of breakthrough medical devices to worldwide markets, leveraging a patented, disruptive technology called Coaptive Ultrasound which is owned by the company. CoapTech devices will reduce health care costs, and improve safety, quality, patient experience, and access to services around the globe.