Quality Associate - IVDR

QuinTalent Inc; Benicia (CA); Hybrid; USD 83,000 - 94,000; Full time

Job summary

A leading company in medical equipment manufacturing is seeking a Quality Associate for a 6-month contract. The role involves updating risk management files and ensuring compliance with IVDR guidelines. Candidates should possess a scientific degree and relevant experience, along with strong problem-solving and communication skills. The position offers a hybrid work environment with competitive pay.

Qualifications

• 3-6 years of experience or equivalent education and experience.
• Basic knowledge of quality assurance principles and theories.

Responsibilities

• Facilitating risk management assessments and updating risk plans.
• Coordinating meetings with stakeholders to gather risk data.
• Supporting migration of product risk management files.

Skills

Critical Thinking

Problem Solving

Coordination

Teamwork

Communication

Technical Skills

Education

Bachelor’s degree or equivalent in a scientific or technical field

Tools

SAP

EtQ

Veeva

Microsoft Office

Visio

Job description

This range is provided by QuinTalent Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $45.00/hr

Direct message the job poster from QuinTalent Inc

Work Environment

Hybrid - 8am - 5 pm Monday to Friday, with 3 days on-site every week.

Contract Duration

6 months, with a pay rate of $40/hour to $45/hour.

Role Overview

The candidate needs to have an understanding of risk, primarily organizing information, identifying gaps, converting files, etc.

The Quality Associate will assist in updating and consolidating legacy product risk management files related to IVDR.

Key Responsibilities:

1. Facilitating risk management assessments, updating risk plans and reports, and consolidating product system hazard analysis files according to company procedures and standards.
2. Coordinating and facilitating meetings with cross-functional stakeholders to gather complete and accurate risk data, identify new risks, and update risk profiles.
3. Escalating significant events to management for further action.
4. Supporting the migration of product risk management files into the eQMS system, ensuring proper documentation and linkage to legacy DHF binders.
5. Assessing legacy risk documentation against current IVDR guidelines and identifying gaps.
6. Assisting with other IVDR-related documentation updates and gap assessments, including migration into eQMS.
7. Adapting to a dynamic environment with shifting priorities, maintaining patience and support for cross-functional teams.
8. Working independently with a sense of ownership and accountability.

Qualifications:

1. Bachelor’s degree or equivalent in a scientific or technical field.
2. 3-6 years of experience or equivalent education and experience.
3. Basic knowledge of quality assurance principles and theories.
4. Understanding of Medical Device/GMP/ISO regulations (ISO 14971, ISO 13485, MDSAP, FDA CFR Part 820).
5. Fundamental understanding of risk management regulations and applications.
6. Excellent critical thinking, problem-solving, coordination, teamwork, communication, and technical skills.
7. Experience with SAP, EtQ, and/or Veeva.
8. Proficiency in Microsoft Office and Visio.

Additional Details:

• Seniority level: Mid-Senior level
• Employment type: Contract
• Job function: Manufacturing and Healthcare Provider
• Industry: Medical Equipment Manufacturing