Director, QA & Regulatory Compliance

Company: CyberCoders
Location: Winston Salem
Posted on: March 27, 2020

Job Description:

Minimum Required Skills Quality Systems, GMP, Regulatory Affairs, Quality Assurance, Audits, Documentation, FDA, compliance auditing If you are a Director of QA Regulatory Compliance with cGMP Medical Device experience, please read on Job Title Manager, QA Regulatory Compliance Location Winston-Salem, NC - RELOCATION ASSISTANCE PROVIDED Salary 130,000 - 150,000 Top Reasons to Work with Us We are a growing medical device company that specializes in single use technologies for cell therapy, biotechnology, blood transfusions, and the pharma industry. We design and supply custom use systems for processing cell based and biological fluids. What You Will Be Doing Manages staff and activities for quality system requirements including internal and external audits, document control, final product release, complaint handling, corrective actions, incoming inspection activities, management review, quality systemGMP training, corrections and removals, regulatory reporting obligations. Other responsibilities - Manage 5-10 direct reports - Serve as PRRC within the meaning of the EU MDR 2017745 Article 15 - Maintain ISO 13485 2016 certification - Submit and maintain international product registrations to individual country requirements What You Need for this Position Required - B.S. degree (preferably in STEM) - 5 years of experience in Medical Device, GMP pharmaceuticals, biologics, regulated product industry - 3 years experience managing direct reports - Authored 5-10 technical submissions that were approved by the FDA for commercialization Nice To Have - Six Sigma Green Belt certification. What's In It for You We offer a comprehensive compensation package including but not limited to - A competitive base salary (130,000 - 160,000) - Full benefits (Medical, Dental, Vision) - Relocation assistance - Collaborative culture - Clean facility - Employee development and training opportunities - Several career paths - we love to promote from withinSo, if you are a Director, QA Regulatory Compliance with experience, please apply today Or email your resume to sophia.kaahacybercoders.com Applicants must be authorized to work in the U.S.Please apply directly to by clicking 'Click Here to Apply' with your Word resume Looking forward to receiving your resume and going over the position in more detail with you. - Not a fit for this position? Click the link at the bottom of this email to search all of our open positions. Looking forward to receiving your resume CyberCoders CyberCoders, Inc is proud to be an Equal Opportunity Employer All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law. Your Right to Work - In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire. Copyright 1999 - 2020 . CyberCoders, Inc. All rights reserved.

Keywords: CyberCoders, Winston-Salem , Director, QA & Regulatory Compliance, Executive , Winston Salem, North Carolina