ATL is searching for an energetic, dynamic and knowledgeable person to help our worldwide quality team keep in compliance. Helping the Global Director of Quality Assurance and Regulatory Affairs by planning, developing and improving quality processes by administrating the corporate global QMS systems in all locations is one of the great tasks this person would be responsible to complete, review and update as needed. Our ideal candidate would have extensive knowledge with 21 CFR part 820, ISO 13485 and ISO 9001 standards. We are looking for someone who has expert knowledge of CAPA, Non-Conforming Material, Customer Complaints, Document/Record Control, Change Management, Continuous Process Improvement, Process Validation, Statistical Process Control, Supplier Management, Internal Audit systems. ISO 13485/9001/AS9100 Lead Auditor Certification and audit experience and supervising a team experience is expected.
However, it would be beneficial to have these preferred skills;
- FDA Regulatory 510K listing and reporting
- Hosting FDA & customer audits
- Software Validation
- Bilingual Spanish or Mandarin Chinese
- ASQ Certification: CMQ/OE, CQA, CQE, CQPA, CQIA, CSQE,
- Six Sigma
- RAPS certification
If you are interested and have at least 5 years of experience in a manufacturing environment of medical devices and/or electrical components and assemblies and/or other regulated industries, please visit the website at https://atltechnology.applicantpro.com/jobs/ to submit your resume.