Specialist, Process Engineer at Pandora focused on process quality control and manufacturing efficiency optimization. Collaborating across teams to implement innovative technologies and enhance production processes.
About the role
- Quality Engineer leading QA activities for IVS projects in Costa Rica, ensuring compliance with international standards and regulations. Supporting project execution with documentation and stakeholder collaboration.
Responsibilities
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
System Study Engineer for HVDC systems performance within Hitachi Energy. Collaborating with a skilled team on performance studies and project lifecycle involvement.
R&D Engineer specializing in short‑circuit performance within Hitachi Energy's Power Transformers organization. Developing technical expertise and contributing to reliability and robustness of power transformers.
Junior Environmental Engineer at Nexa in Lima managing environmental commitments and coordinating monitoring efforts with consultants.
Project Engineer Facilities managing diverse projects in Ghent to ensure high sustainability standards. Collaborating with teams on construction, renovation, and efficiency initiatives.
Graduate Engineer role at Teleflex focusing on manufacturing processes in the medical technology sector. Collaborating on new product development and engineering support initiatives to enhance patient care.
Project Engineer managing Land Development designs at BKF, a civil engineering and surveying firm. Focus on site development, utility system design, and collaboration with stakeholders.
Instrument and Electrical Reliability Engineer at LyondellBasell in Texas. Supporting maintenance and reliability to enhance plant performance at HDPE manufacturing facility.
Engineer in Energy Technology managing projects related to energy supply and decarbonization. Collaborating with trading and controlling teams in a hybrid work environment.
Principal Engineer responsible for reviewing construction documents for compliance with California standards at CSG Consultants. Ensuring adherence to safety and structural regulations while supervising a team.