QA Scientist IV - IVD Medical Devices (Madison, WI)
Do you have significant QA experience in In Vitro Medical Devices and are looking for a leading biotech company you can continue growing your career in? This high level QA Scientist role is made for you!
What You'll Do: In this role you'll play a key role in assuring product quality and compliance to quality system requirements (QSR) pertaining to the manufacture of in vitro diagnostic medical devices.
Work independently and with cross-functional teams to assure QSR compliance with applicable regulations (US FDA 21CFR820, Europe IVDR, Health Canada regulations, MDSAP requirements, ISO 13485, etc.).
Review and assist in the development of reports, protocols, and SOPs for new and current products.
Execute the following activities when appropriate:
Review and approve batch records, stability data and validation results to ensure that products meet requirements.
Review and approve technical literature content for accuracy and consistency.
Assess the scope and inventory impact of nonconforming product situations; approve disposition plans of inventory product on hold and assist in the disposition planning for nonconforming product.
Demonstrate leadership within the Product Quality Team.
Act as QA lead on new product development cross-functional teams.
Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
Embracing and be open to incorporating the company's 6Emotional & Social Intelligence (ESI) core principles in daily work.
Understand and comply with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
Bachelor of Science degree in life science or chemistry.
Minimum of 7 years’ experience that includes time spent working in Medical Device industry. Experience should be in manufacturing, process development, quality control or quality assurance.
Five (5) years Working knowledge of ISO13485 requirements. Direct experience working in an FDA regulated system.
Proven ability to work constructively with a broad range of people, backgrounds, and functions.
Ability to apply effective critical thinking skills in complex problem solving and decision making to achieve positive results.
Ability to develop concise, clear written communication and presentations that contain both analysis and possible solutions.
Ability to effectively prioritize and manage workload in an environment with frequent interruptions and changing priorities and timelines.
Experience leading department or corporate projects in a positive team environment.
Proficiency with basic word processing and spreadsheet software.
Preferred (Not Required) Experience:
1. Direct experience in quality field related to in vitro diagnostic medical devices.
Apply Now and move your career forward with an exciting and highly respected biotech leader! Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.