Quality & Regulatory Affairs Analyst
Share
Job Location:
Arlington, TX - USA
Monthly Salary:
Not Disclosed
Posted on:
19 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Summary
The Quality & Regulatory Affairs Analyst (Research Engineering Scientist Assoc V) will deliver hands-on quality management and regulatory affairs solutions to a wide range of businesses including manufacturing distribution logistics construction health care and government. Contribute to TMACs wide array of services that accelerate profitable growth by developing and improving profits products processes technologies and people.
Essential Duties And Responsibilities
Quality Management Systems: Assist in the development implementation and maintenance of Quality Management Systems ( QMS ) for TMAC customers in accordance with various standards including but not limited to: ISO 9001 AS9100 AS9110 ISO 13485 & IATF 16949. Conduct internal audits to ensure compliance with QMS and regulatory requirements. Develop and improve quality procedures work instructions and policies to maintain compliance and documentation requirements. Training & Education: Train and educate Customers and TMAC Personnel (including TMAC regions across the state) on quality management systems applicable standards regulatory requirements and best practices. Educate internal and external teams on new regulations standards and updates in impacted industries. Attend training and professional development courses to stay informed of new standards policies procedures and practices. Present technical sessions at industry conferences and tradeshows to represent TMAC . Audit Preparation & Support: Prepare for and support external audits and inspections for TMAC customers. Address and respond to audit findings non-conformities and observations. Recommend improvements and solutions. Design prepare and conduct internal audits for TMAC customers. Report on audit findings & assist with solutions. Environmental Systems: Integrate QMS standards with Environmental Mgt Systems ISO 14001 and Safety Mgt Systems ISO 45001) as required by TMAC customers for compliance. Project Management: Source and follow up on leads develop proposals and follow up with potential customers throughout the sales process. Provide management consulting operational excellence & product / process engineering solutions to accelerate the profitable growth of TMAC customers. Manage multiple overlapping customer projects with strong attention to detail excellent organizational and interpersonal skills and maintain customer/sponsor satisfaction. Performs other duties as assigned.
Minimum Qualifications
Bachelors degree in STEM or related field. Ten (10) years industry experience in manufacturing .or an equivalent mix of education and relevant experience in similar role. Five (5) years of experience conducting internal audits ( ISO 9001 AS9100 AS9110 ISO 13485 IATF 16949). Demonstrated experience in process control tools (Statistical Process Control Design Of Experiments Measurement System Analysis etc.).
Preferred Qualifications
Masters Degree in a STEM or related field. AS9100 or ISO 13485 Certified Lead Auditor. Experience designing and implementing quality management systems in industry (at least 10 implementations). Strong foundation in manufacturing processes and process improvement methodologies. Experience in Aerospace Defense or Medical Device Manufacturing industries.
Work Schedule
Monday-Friday; 8:00am-5:00pm. Hybrid position office space available but most work will be conducted on-site with customers at their facilities. Regular travel to various client sites which may be located regionally or across the state of Texas. Some interstate travel may be required as customer demand and grant obligations require.
The Quality & Regulatory Affairs Analyst (Research Engineering Scientist Assoc V) will deliver hands-on quality management and regulatory affairs solutions to a wide range of businesses including manufacturing distribution logistics construction health care and government. Contribute to TMACs wide array of services that accelerate profitable growth by developing and improving profits products processes technologies and people.
Essential Duties And Responsibilities
Quality Management Systems: Assist in the development implementation and maintenance of Quality Management Systems ( QMS ) for TMAC customers in accordance with various standards including but not limited to: ISO 9001 AS9100 AS9110 ISO 13485 & IATF 16949. Conduct internal audits to ensure compliance with QMS and regulatory requirements. Develop and improve quality procedures work instructions and policies to maintain compliance and documentation requirements. Training & Education: Train and educate Customers and TMAC Personnel (including TMAC regions across the state) on quality management systems applicable standards regulatory requirements and best practices. Educate internal and external teams on new regulations standards and updates in impacted industries. Attend training and professional development courses to stay informed of new standards policies procedures and practices. Present technical sessions at industry conferences and tradeshows to represent TMAC . Audit Preparation & Support: Prepare for and support external audits and inspections for TMAC customers. Address and respond to audit findings non-conformities and observations. Recommend improvements and solutions. Design prepare and conduct internal audits for TMAC customers. Report on audit findings & assist with solutions. Environmental Systems: Integrate QMS standards with Environmental Mgt Systems ISO 14001 and Safety Mgt Systems ISO 45001) as required by TMAC customers for compliance. Project Management: Source and follow up on leads develop proposals and follow up with potential customers throughout the sales process. Provide management consulting operational excellence & product / process engineering solutions to accelerate the profitable growth of TMAC customers. Manage multiple overlapping customer projects with strong attention to detail excellent organizational and interpersonal skills and maintain customer/sponsor satisfaction. Performs other duties as assigned.
Minimum Qualifications
Bachelors degree in STEM or related field. Ten (10) years industry experience in manufacturing .or an equivalent mix of education and relevant experience in similar role. Five (5) years of experience conducting internal audits ( ISO 9001 AS9100 AS9110 ISO 13485 IATF 16949). Demonstrated experience in process control tools (Statistical Process Control Design Of Experiments Measurement System Analysis etc.).
Preferred Qualifications
Masters Degree in a STEM or related field. AS9100 or ISO 13485 Certified Lead Auditor. Experience designing and implementing quality management systems in industry (at least 10 implementations). Strong foundation in manufacturing processes and process improvement methodologies. Experience in Aerospace Defense or Medical Device Manufacturing industries.
Work Schedule
Monday-Friday; 8:00am-5:00pm. Hybrid position office space available but most work will be conducted on-site with customers at their facilities. Regular travel to various client sites which may be located regionally or across the state of Texas. Some interstate travel may be required as customer demand and grant obligations require.
Required Experience:
IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
An educational leader in the thriving North Texas region, UTA nurtures minds within an environment that values excellence, ingenuity, and diversity.
