Quality IVS Projects Engineer Empleos

Descripción del trabajo

This role ensures regulatory compliance, supports validations, strengthens technical documentation, and enables risk‑based decisions that drive future product and process improvements. This role offers the opportunity to drive quality excellence within high‑impact innovation projects and contribute to processes that directly affect patient safety and product performance.

Responsabilidades

Defines project requirements, coordinates execution, and ensures that all deliverables meet regulatory, quality, and timeline expectations
Ensures full compliance of project activities with global medical device regulations—including MDSAP, MDR, ISO 13485, and FDA requirements—as well as the Coloplast Management System
Supports internal and external audits through expert knowledge and documentation readiness
Oversee the creation, maintenance, and training of quality documentation for IVS projects. Responsibilities include managing DMRs, specifications, test methods, risk assessments, and change control activities in accordance with corporate and local requirements
Provides oversight for validations related to processes, equipment, software, and test methods, ensuring alignment with regulatory and procedural standards. The role approves protocols and reassesses validations as needed due to risk, regulatory, or process changes, and leads investigations to resolve abnormal test results
Owns non-conforming events and CAPAs related to IVS projects
Leads process and product risk management activities by identifying, evaluating, mitigating, and documenting risks. The engineer also supports the definition of specifications for legacy products and communicates risk status and KPIs to key stakeholders
Coordinates sample collection for design verification testing and ensure proper testing execution through Production and the QA Laboratory
The role maintains accurate and compliant quality documentation for IVS projects and supports Quality Management Review (QMR) requirements
The engineer provides backup support to QA team members when necessary and makes quality‑related decisions within the authorized training scope, ensuring continuity of quality operations across the site

Requisitos

Bachelor’s degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering, or a related field
A minimum of 5 years of experience in medical device manufacturing with strong QA expertise
English proficiency at B2 level or higher
Strong analytical and data interpretation skills
Demonstrated ability to work effectively with cross‑functional and cross‑site teams
Ability to manage multiple priorities in a fast‑paced environment
Availability to travel approximately 20–25 days per year

Deseable

Experience leading or supporting innovation projects
Knowledge of MS Project or similar project management tools
Master’s degree in project management or a professional certification (e.g., PMP)

Lo que ofrecemos

Medical insurance
asociation
gym
cafeteria subsidy
free transportation

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Quality IVS Projects Engineer

Descripción del trabajo

Responsabilidades

Requisitos

Deseable

Lo que ofrecemos

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