Director of Quality Assurance
Gainesville, FL 32615
Reference Number: 2410
Director Quality Assurance – Biomedical / Medical Device – Gainesville, FL
Excellence: If this is your passion, if you love being a hands on Quality Engineering leader, if you provide Excellence to manufacturing and Excellence in implementing 21 CFR 210/211 compliance then you owe it to yourself to consider that this may be the career and employer of your dreams.
The Challenge, Culture & Company: The bottom line here is this role will allow you to truly make an IMPACT on a team, on processes, and in improving patient’s quality of life. The number one challenge you will face is to join a successful medical device company that is expanding their product line into and overseeing the processes to achieve their FDA 21 CFR Part 210/211 compliance. You WILL make a difference. My client will empower you to drive change, to lead a small team, to mentor, to influence decisions, and to interact with the company’s senior management team. Does a fast-paced wide-ranging job, where every day will look different than the one before, excite you? Do you thrive in a work-hard play-hard atmosphere?
The Package: Competitive and Impressive. Base, Bonus, Relocation & Benefits.
So are you up to the challenge?
*******IMMEDIATE INTERVIEWS ARE BEING SCHEDULED FOR NEXT WEEK*******
Simple Requirements: 1. You MUST have experience bringing a company into compliance with FDA 21 CFR Part 210/211. This is non-negotiable. 2. You MUST have strong FDA relationships and have lead successful Audits. 3. You must have experience leading cGXX (cGMP, QSR and cGTP) quality operations. 4. You MUST function as a Subject Matter Expert in your field…10+ years of experience. 5. You MUST have experience overseeing quality functions in a FDA 13485 compliant manufacturing operation.
Research & Recruitment Specialist
Paula joined the Morisey-Dart Group in August of 2017. She is the firm’s research and recruitment specialist for the medical device and precision machining/manufacturing teams. She is responsible for sourcing and recruiting, lead generation, internet research and various other responsibilities within both the medical device and precision machining industries.
With 25 years at Xerox Corporation in New York, Paula had a prosperous and noteworthy career where she excelled during her tenure. She brings her vast knowledge and expertise in procurement, supply chain, contract administration and project management to the firm. She is a creative and natural problem-solver with proven success in developing and implementing new procedures and processes as well as integrating newly acquired subsidiaries.
Now, she’s using her expertise to build a network of solid relationships in the medical device and precision machining industries that help hiring managers find the top talent they need to improve their organizations.
Paula is Lean Six Sigma certified (Green Belt), has a Master of Science in business management and a Bachelor of Science in education.