US Quality Assurance Specialist - Brasseler

a wide range of Quality Systems regulatory requirements and associated quality activities to support a medical device manufacturing line.  The person assists in investigating and supporting regulatory affairs activities, assists in the development of procedures, and coordinates with different departments to ensure quality system requirements are met.
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* KEY RESPONSIBILITIES:

** Review records and documents, for completeness and compliance with Quality System Requirements and ISO requirements. Assist in company wide training on general quality principles and specific procedural requirements.

Teach and lead others in developing quality skills.
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* WORK EXPERIENCE:

** Familiarity with FDA medical device regulations and ISO 13485 is required

Experience in QA support of automated medical device manufacturing.

Experience with 3D Printing and Thermoforming a plus.  Experience in Process Validations (IQ, OQ, PQ)  
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* PREFERRED EDUCATION:

** Bachelor’s Degree (preferred) and four years related experience.
** KNOWLEDGE, SKILLS &

COMPETENCIES:

** Ability to read and interpret general technical/quality procedures and quality system regulations.

Ability to write and create medical device manufacturing SOPs and Work Instructions.  Ability to create reports, business correspondence, and procedure manuals

Ability to effectively present information and respond to questions verbally, in writing, and in group presentations While performing the duties of this job, the employee routinely is required to sit for extended periods of time; talk and hear; use hands to keyboard, finger, handle, and feel; stoop, kneel, crouch, twist, reach, stretch and lift up to 15 pounds

Over  Henry Schein borrowed $500 to start a corner pharmacy in Queens, New York, nearly 30 miles from Melville, New York, where our corporate headquarters resides today. In the depths of the Great Depression, Henry and his wife Esther made a bold bet on their future all while living their values of helping health happen and caring for their team and the community they served.

Their belief paid off far beyond what Henry and Esther might have dared to imagine in 1932. Henry Schein is now a Fortune 500 Company powered by a network of people and technology to be the world’s leading provider of health care products, services and solutions to office-based dental and medical practitioners.  Since our founding we have stayed true to Henry and Esther’s values which has allowed us to evolve, expand, and grow our Company.

Now serving more than 1 million customers in 33 countries and territories, the Company's network of trusted advisors provides more than 1 million customers globally with more than 300 valued solutions that help improve operational success and clinical outcomes.  We invite you to join approximately 25,000 Team Schein Members, who are critical to our success and are at the core of our  as our founders would have wanted.

We live those values by ensuring that our culture focuses on the  of our team, which we accomplish by providing a  for individuals to develop and contribute authentically, with opportunities to and the communities where we live and work.  No matter the role you are seeking, we encourage you to come be a part of a team that makes the world a healthier place.

Henry Schein embraces diversity and is committed to providing equal opportunity to employees and applicants. If you are unable or limited in your ability to complete the application process, including the use or access of , as a result of a physical or mental impairment, you can request reasonable accommodations.

Please e-mail the appropriate email address below with the type of accommodation you are requesting. Please include your first and last name, phone number, position for which you are interested in applying and geographic location in your request.

US Candidates:  UK and Ireland Candidates: UKHS and New Zealand Candidates: APACCareers

Malaysia Candidates: CNHRItaly Candidates: risorse.umane### Workplace Remote Types It is important to us to offer different types of work arrangements. Please see the types we offer below:
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