Senior Quality Assurance Director

4 weeks ago


Kenosha, Wisconsin, United States Tecomet Full time

Director of Quality Assurance and Regulatory Compliance



Tecomet is seeking a highly skilled Director of Quality Assurance and Regulatory Compliance to lead our quality assurance and regulatory affairs systems. This senior-level role will oversee the development, implementation, and maintenance of quality systems that ensure patient and employee safety, achieve customer quality requirements, and maintain compliance with FDA and ISO regulations.



The ideal candidate will have a strong background in quality engineering, experience in a regulated environment, and leadership skills to mentor and support functional team members. Responsibilities will include overseeing the development of quality systems for planning, design of experiments, ISO 13485, quality function development, and design for manufacturability.



The Director of Quality Assurance and Regulatory Compliance will also be responsible for integrating the quality function with manufacturing, optimizing the continuous quality improvement process, and reducing costs. This role will require strong organizational, people, and leadership skills, as well as the ability to communicate effectively with internal and external stakeholders.



The estimated salary for this position is $120,000 to $160,000 per year, depending on experience. If you are a motivated and results-driven professional with a passion for quality and regulatory compliance, we encourage you to apply.



Responsibilities:



1. Quality System Development



Develop, implement, and maintain quality systems that ensure patient and employee safety, achieve customer quality requirements, and maintain compliance with FDA and ISO regulations.



2. Leadership and Mentorship



Lead and mentor a team of quality professionals, providing guidance and support to ensure the successful implementation of quality systems.



3. Integration with Manufacturing



Integrate the quality function with manufacturing, optimizing the continuous quality improvement process and reducing costs.



4. Regulatory Compliance



Ensure compliance with FDA and ISO regulations, as well as other relevant laws and regulations.



5. Communication and Collaboration



Communicate effectively with internal and external stakeholders, including customers, suppliers, and regulatory authorities.



Requirements:



1. Education



Bachelor of Science in Engineering or related field.



2. Experience



5+ years of quality engineering experience in a manufacturing environment, with 2+ years of experience in a regulated environment.



3. Skills and Abilities



Strong organizational, people, and leadership skills, as well as the ability to communicate effectively with internal and external stakeholders.



4. Knowledge and Certifications



ISO 13485, EN46001, ISO 14001, Federal and State laws and regulations, and knowledge of International Quality and Environmental Standards.



5. Soft Skills



Strong auditing background, ability to speak in front of people, flexibility and adaptability, and the ability to create and manage high-performing work teams.



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