ATL Technology is searching for a professional, knowledgeable and experienced quality manager to be an integral part of our quality team. This role requires an energetic and motivated self-starter with a passion for quality, compliance and continual improvement.
Duties & Responsibilities:
Define quality related requirements, lead employees with the processes used to develop, establish, and maintain quality compliance programs, policies, procedures, and controls to ensure that all products conform to cGMPs, established standards, agency regulations, guidelines, and industry compliance trends.
Develop ATL personnel through training and the hiring process to support continually increasing requirements supporting new and existing products and regulatory requirements.
Proactively endorse the concepts of COQ, COPQ and Six Sigma/Lean.
Move the organization to develop Quality by focusing on Quality Assurance, Quality by Design, Validation and Statistical Process Control among other Quality Assurance tools.
Effectively prepare the company for successful FDA inspections, certified body and customer audits.
Participate as an effective member of local Site Management Team(s) and the Global Quality Management Team, contributing to both Site and Global objectives and initiatives.
If you are interested in the position and have the following experience under your belt;
Bachelor's Degree or equivalent combination of education and experience.
At least 5 years of experience in a quality environment of a manufacturing environment of medical devices and/or electrical components and assemblies or other regulated industries,
At least 5 years management of employees
Expert knowledge of ISO 13485 or 9001 with Lead Auditor Certification.
We would be very interested in reviewing your resume.
Extra attention will be given to resumes that have experience with these preferred items.
FDA Regulation, specifically 21 CFR Part 820
Medical Device Manufacturing
ASQ or RAC Certification
Clean Area/Room Environment
Document/Record Control Systems
Root Cause Analysis
Sterilization & Packaging
Internal Number: 1145176
About ATL Technology LLC
ATL Technology is focused on delivering exactly to our client’s medical industrial, and commercial needs. We are a vertically integrated device manufacturer with the versatility to take on a wide range of projects. Unlike larger companies that have become set in their ways, ATL can change and adapt to our client’s needs in order to create the exact product that they need. Material sourcing, design, prototyping, production, and manufacturing are some of the services that our experienced engineers and staff are can provide. We offer every service necessary so that our clients know the best work goes into the project.