Quality Control / Quality Assurance Specialist
Company: Arthrex
Location: Naples
Posted on: May 16, 2022
Job Description:
Requisition ID: 52740 Title: GCP QA Specialist - Principal
Division: Arthrex, Inc. (US01) Location: Naples, FL Arthrex is a
global medical device company and a leader in new product
development and medical education in orthopedics. Arthrex is
actively seeking a GCP QA Specialist Principal to work directly
with the Engineering & Clinical Research departments within Arthrex
to ensures that all activities are performed in accordance with all
Good Clinical Practices (GCPs), company policies, and applicable
regulations to provide timely delivery of high-quality clinical
data to support global registration and commercialization of
Arthrex products. Excellent communications and analytical skills,
strong technical project management skills and a Bachelors degree &
10 years of experience in a Clinical Quality, Regulatory, or
Clinical-adjacent role will be essential for this position. Join
our talented team at a global medical device company focused on
Helping Surgeons Treat Their Patients Better. Essential Duties and
Responsibilities:
- Leads in the development of Quality (GCP) program for Clinical
Research Team.
- Navigates and communicates the Clinical Regulatory landscape of
multiple regions as appropriate to Medical Devices, Biologic
products, and medical consumables.
- Maps current Clinical Research processes, reviews existing
essential documentation, creates and implements plans for gap
closure.
- Collaborates with Clinical Research Team on educational
initiatives to develop GCP content and train Arthrex
personnel.
- Reviews Clinical Investigation Plans for adherence to
procedural requirements and GCPs.
- Compiles and distributes information supporting GCP impact for
prospective, ongoing, and completed studies related to the
Regulatory Status of Arthrex Product.
- Collaborates with Clinical Research Team to Audits prospective
Clinical research Organizations to determine Supplier
Qualification.
- Liaises with Regulatory Affairs and Quality in-country partners
to assess risk and support the development of OUS Quality
programs.
- Verifies and keeps metrics related to the effectiveness of
completed changes and risk mitigation activities and appropriately
supports remediation activities.
- Communicates effectively with internal and external business
partners, including Orthopedic Research, Regulatory Affairs,
Product Management, Engineering, Quality, IT, and other functions
as appropriate to achieve the company quality objectives.
- Professionally communicates critical time-sensitive
information, exceptions, and changes to affected parties.
- Participates in audits and inspections of Clinical Research
activities. Incidental Duties: The above statements describe the
general nature and level of work performed in this job. They are
not intended to be an exhaustive list of all duties, and indeed
additional responsibilities may be assigned, as required, by
management. Education and Experience:
- Bachelors degree required.
- Ten (10) years of experience in a Clinical Quality, Regulatory,
or Clinical-adjacent role within the regulated industry (Medical
Device, Pharma, or Biotech) required. Knowledge and Skill
Requirements/Specialized Courses and/or Training:
- Thorough knowledge of US FDA Code of Federal Regulations (21
CFR 11, 50, 54, 56, 812, 814), (EU) 2017/745, International
Conference on Harmonization (ICH) and International Standards
Organization (ISO) 14155:2020, 13485:2016, 14971:2019 is
required.
- Clinical Research Certification or Quality Certification is
required OR obtained in one year.
- Comprehension of medical terminology, or can reference
literature for understanding.
- Proficient software skills: Word/ Excel/ Power Point/database.
Machine, Tools, and/or Equipment Skills: PC, database, research
tools, internet research tools. All qualified applicants will
receive consideration for employment without regard to race, color,
religion, age, sex, sexual orientation, gender identity, national
origin, disability or protected veteran status.
Job Requirements:
Keywords: Arthrex, Cape Coral , Quality Control / Quality Assurance Specialist, Other , Naples, Florida
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