Quality IVS Projects Engineer
Coloplast
full-time
Posted on:
Location Type: Office
Location: Cartago • Costa Rica
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About the role
- 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.
Requirements
- 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.
Benefits
- Medical insurance
- asociacion
- gym
- cafeteria subsidy
- free transportation
- other
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
project managementquality assurancerisk assessmentvalidationregulatory compliancedata interpretationspecifications managementtest methodschange controlCAPA
Soft Skills
analytical skillscommunicationcross-functional teamworkorganizational skillsproblem-solvingtime managementleadershipadaptabilitydecision-makinginterpersonal skills