Quality Systems Supervisor
3 weeks ago
Seeking Quality Systems Supervisor with experience in manufacturing process controls with experience in injection molding or contract manufacturing. You will be responsible for regulatory requirements; 21 CFR Par 11, 21 CFR Part 820, ISO-13485, regulatory submissions to the FDA and other regulatory agencies. Ideal candidate will have a degree in a discipline related to regulatory affairs with 5 years experience in a regulatory environment, or in quality systems with emphasis in regulatory submissions, supplier audits and will also oversee quality technicians.
Must have experience applying regulatory requirements to a corporate and multi-site company with understanding of the medical device industry directives and the ability to work with FDA and international standards. You will also support validation efforts of the company data-base for quality systems MQ-1, review complaint files for closure and ensure investigations conclusions are clearly documented as part of the record. CAPA compliance with FDA guidelines experience is also a nice to have.
LOCAL candidates only to the Tucson, AZ location, and must be authorized to work in the U.S. without sponsorship.
NO ONE IS USELESS IN THIS WORLD WHO LIGHTENS THE BURDEN OF IT TO ANYONE ELSE – Charles Dickens
FOR IT IS IN GIVING THAT WE RECEIVE – Francis of Assisi
THERE IS ONLY ONE WAY TO SUCCEED AT ANYTHING AND THAT IS TO GIVE EVERYTHING – Vince Lombardi
NEVER TELL PEOPLE HOW TO DO THINGS. TELL THEM WHAT TO DO AND THEY WILL SURPRISE YOU WITH THEIR INGENUITY. – General George S Patton
LIFE IS 10% WHAT HAPPENS TO YOU AND 90% HOW YOU RESPOND TO IT – Lou Holtz
BE THE CHANGE YOU WISH TO SEE IN THE WORLD – Mahatma Gandhi
ONE LEARNS PEOPLE THROUGH THE HEART, NOT THE EYES OR THE INTELLECT – Mark Twain
WE CAN’T HELP EVERYONE, BUT EVERYONE CAN HELP SOMEONE – Ronald Reagan
LET ME WIN, BUT IF I CANNOT WIN, LET ME BE BRAVE IN THE ATTEMPT – Motto of the Special Olympics
FAITH IS TAKING THE FIRST STEP EVEN WHEN YOU DON’T SEE THE WHOLE STAIRCASE – Martin Luther King, Jr.
PEACE BEGINS WITH A SMILE – Mother Teresa
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