- Working knowledge of Regulatory Requirements:IS013485, AS9100, ITAR, 21 CFR Part 11, REACH/RoHS, CMRT,
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Quality Engineer - Frederick, United States - Bridgeway Professionals Inc
Description
Our QE will work with the team to monitor and improve the quality of our processes and outputs.You will be responsible for designing quality standards, developing quality control systems, and leading cross-functional teams in problem-solving, resulting in innovative, solid corrective actions.
A successful quality engineer should be an exemplary problem solver and diligent at ensuring our processes and products consistently meet our customer requirements and all regulatory standards.
Quality Engineer Responsibilities:
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Developing and implementing quality standards and systems
Monitoring and analyzing quality performance and have working knowledge of statistical controls.
Working knowledge of
Quality Tools:5why, fishbone, APQP, PPAP, PFMEA, SPC, MSA,
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Collaborating with operations to develop and implement controls and improvements.
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Ensure that workflows, processes, and products comply with customer and regulatory requirements.
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Lead the investigation and troubleshooting of product or production issues.
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Drive corrective action efforts, solutions, and continual improvements.
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Customer contact for quality issues and owner of scorecard feedback on quality.
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Conducting customer audits and internal audits and assisting with external audits.
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Responsible for dealing with supplier issues, including issuing Supplier Corrective Actions and follow-through.
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Quality Representative at MRB and Product Launches for NPI.
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Responsible for maintaining document control.
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Responsible for supplier management, including Approved Vendor List and managing regulatory and certification updates.
Quality Engineer Requirements:
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Minimum of 5+ years of experience in Quality Engineering in the medical manufacturing industry.
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Minimum of bachelor's degree in engineering (or technical degree).
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Strong GD&T working knowledge.
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Proficient in Microsoft Word, Excel, and PowerPoint
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Strong communication and interpersonal skills
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Strong analytical and problem-solving skills
FOR IT IS IN GIVING THAT WE RECEIVE – Francis of Assisi
NO ONE IS USELESS IN THIS WORLD WHO LIGHTENS THE BURDEN OF IT TO ANYONE ELSE – Charles Dickens
PEACE BEGINS WITH A SMILE – Mother Teresa
BE THE CHANGE YOU WISH TO SEE IN THE WORLD – Mahatma Gandhi
FAITH IS TAKING THE FIRST STEP EVEN WHEN YOU DON'T SEE THE WHOLE STAIRCASE – Martin Luther King, Jr.
LIFE IS 10% WHAT HAPPENS TO YOU AND 90% HOW YOU RESPOND TO IT – Lou Holtz
ONE LEARNS PEOPLE THROUGH THE HEART, NOT THE EYES OR THE INTELLECT – Mark Twain
THERE IS ONLY ONE WAY TO SUCCEED AT ANYTHING AND THAT IS TO GIVE EVERYTHING – Vince Lombardi
WE CAN'T HELP EVERYONE, BUT EVERYONE CAN HELP SOMEONE – Ronald Reagan
NEVER TELL PEOPLE HOW TO DO THINGS. TELL THEM WHAT TO DO AND THEY WILL SURPRISE YOU WITH THEIR INGENUITY. – General George S Patton
LET ME WIN, BUT IF I CANNOT WIN, LET ME BE BRAVE IN THE ATTEMPT – Motto of the Special Olympics
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