Quality Specialist III

INSTRUMENTATION LABORATORY COMPANY • Waukesha, WI • 1h ago

JOB REQUIREMENTS: Job Information Number ICIMS-2026-10768 Job function
QA&RA Job @type Full-time Location Werfen - Waukesha - Waukesha,
Wisconsin United States Country United States Shift 1st About the
Position Introduction Werfen is a growing, family-owned, innovative
company founded in 1966 in Barcelona, Spain. We are a worldwide leader
in specialized diagnostics in the areas of Hemostasis, Acute Care
Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our
Original Equipment Manufacturing (OEM) business line, we research,
develop, and manufacture customized assays and biomaterials. We operate
directly in 30 countries, and in more than 100 territories through
distributors. Our Headquarters and Technology Centers are located in the
US and Europe, and our workforce is more than 7,000 strong. Our success
comes from a specific focus in these rapidly evolving diagnostic areas,
our commitment to customers, and our dedication to innovation and
quality. We\'re passionate about providing healthcare professionals the
most valuable and complete solutions to improve hospital efficiency and
enhance patient care Overview We are seeking a Quality Specialist
(Quality Assurance Specialist) to join our team at our Waukesha, WI
facility. If you\'ve got the necessary skills and experience to excel in
this position, we want to hear from you. Apply today! This position is
not eligible for sponsorship for work authorization by Immucor, Inc.
Therefore, if you will require sponsorship from us for work
authorization now or in the future, we cannot consider your application
at this time. Quality Assurance Specialist - Quality Specialist -
Medical Device Technology (QA) Responsibilities As a Quality Specialist
(Quality Assurance Specialist), you will be responsible for ensuring
compliance with applicable domestic and international standards and
regulations through process review, approval, audits and systematic
maintenance of quality systems. You will function as a product
development process QA and Change Control team lead, ensuring compliance
to all internal and external design control requirements. The scope and
design of your control activities include software development, design
inputs and outputs, risk management, verification, validation, design
transfer (manufacturing, suppliers and service), change management,
design review, and review of design history files. You will also be a QA
liaison for validation and verification activities. Other
responsibilities include: Conducting compliance audits of complex
documentation and data Serving as QA interface to other departments
and/or partners Managing, mentoring and training staff in our quality
system procedures and the general regulatory... For full info follow
application link. Werfen is an Equal Employment Opportunity company,
committed to selecting, promoting, and compensating individuals
regardless of race, religion, sex, age, national origin, or qualifiable
disability. *** APPLICATION INSTRUCTIONS: Apply Online:
ipc.us/t/BFCC5E2C31F04C8E

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