Quality Assurance Specialist I

Job Title: Quality Assurance Specialist I

Duration: 12 Months Contract

Location: Indianapolis, IN 46256

Shift: Hybrid - 3days oniste and 2days offsite

Position Overview

• The primary responsibility is managing the ETE IVDR/MDR product verification process for products within Roche'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.