IVS Quality Projects Engineer
Coloplast
full-time
Posted on:
Location Type: Office
Location: Cartago • Costa Rica
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About the role
- Lead, manage, and support QA activities for IVS projects at the CAR site, including initiatives related to the Global Operation Plan and CAR QA.
- Define scope and analyze QA project requirements within CAR.
- Ensure successful project execution within defined scope, timelines, and quality expectations.
- Participate in regular meetings and provide project updates to relevant stakeholders.
- Manage, take the lead of project and CAPA related QA IVS activities at CAR site, including root cause analysis
- Monitor and report QA KPIs, risks, and issues to the Head of Quality and other stakeholders.
- Identify opportunities for continuous improvement in quality processes and project execution.
- Manage and control the QA projects in accordance with regulatory compliance by adherence to requirements (MDSAP, MDR, ISO, FDA, etc) and country specific medical device regulations and the Coloplast Management System.
- Actively participate in internal and external audits.
- Manage and maintain QA documentation, including creating, updating, implementing, and training related to IVS projects and requirements for Quality Management Review.
- Provide quality oversight by reviewing, approving, and monitoring all validation activities—across processes, equipment, software, and test methods—to ensure full alignment with procedures and regulatory requirements.
- Lead and maintain comprehensive risk management activities, including conducting and updating process/product risk assessments, ensuring proper identification, evaluation, mitigation, and documentation of risks, and supporting specification-setting for legacy products lacking defined specifications.
Requirements
- Bachelor’s degree in chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
- Minimum 5 years of experience in medical device manufacturing with a deep knowledge of quality assurance methodologies and standards.
- English (minimum B2 level) reading, writing, and speaking in a conversational level
- Excellent numerical skills and understanding of data analysis.
- Ability to interact professionally with all organizational levels across sites
- Ability to manage competing priorities in a fast-paced environment
- Able to travel approximately 20-25 days per year.
Benefits
- Medical insurance
- asociation
- gym
- cafeteria subsidy
- free transportation
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assurance methodologiesroot cause analysisdata analysisrisk managementregulatory complianceMDSAPMDRISOFDAquality management review
Soft Skills
project managementcommunicationnumerical skillsinterpersonal skillsability to manage competing prioritiesorganizational skillsleadershipcontinuous improvementstakeholder engagementprofessional interaction