Title: Quality Assurance Specialist I Duration: 12 months contract Location: Indianapolis, IN 46256
Hybrid - 3days Onsite and 2days Offsite
Responsibilities:
The primary responsibility is managing the ETE IVDR/MDR product verification process for products within client's distributed products portfolio, including determining requirements and controls for those products and completing objective evidence of supplier evaluation and approval.
Manage SCARs (Supplier Corrective Action Requests) and successfully complete them, as well as address other supplier gaps in a timely manner by tracking robust corrective action plans.
Complete onboarding activities for suppliers.
Monitor supplier performance.
Plan and follow up on supplier audits and ensure resulting supplier actions are sufficient to resolve quality issues and are completed in a timely fashion.
Identify and escalate issues as they arise and provide adequate solutions.
Must Have:
Two or more years of experience in Quality or a related function.
Bachelor’s / Master’s degree in Life Science, Data Science, or a related subject or equivalent experience.
Professional experience in a similar role within the medical device sector.
Knowledge of deviation and resolution management.
Expertise in quality systems, standards and regulations, specifically production and/or supplier development processes and standards such as ISO 13485 and ISO 27001.
Strong analytical skills with a focus on essential facts.
Excellent communication skills.
Cultural awareness and experience interacting with global internal and external partners and suppliers.
Leadership mindset with the ability to lead others within an agile organization.
Willingness and flexibility to collaborate cross-continentally in a global team across different time zones (may require early working hours to ensure close collaboration with colleagues in the European Union).
Decisive and able to initiate and complete daily activities and proactively find solutions independently with limited guidance.
Numbers & Facts
Location
Indianapolis, IN
Skills
Analysis Skillsunmatched
Biologyunmatched
Communication Skillsunmatched
Corrective Actionunmatched
Data Scienceunmatched
ISO (International Organization for Standardization)unmatched
Identify Issuesunmatched
Leadershipunmatched
Medical Equipmentunmatched
Onboardingunmatched
Performance Analysisunmatched
Problem Solving Skillsunmatched
Quality Assuranceunmatched
Regulationsunmatched
Time Managementunmatched
Vendor/Supplier Evaluationunmatched
Vendor/Supplier Managementunmatched
🎯
Be found by employers
5,500+ employers search our resume database daily. Add yours to get found by recruiters looking for candidates like you.
Level up your application
Professional resume templates
Browse dozens of recruiter approved resume templates, layouts and formats. Choose your favorite and make it your own in minutes.