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Quality Systems Engineer
hace 2 semanas
**Location**:
Cartago, Costa Rica, CR
**Job Family**: Quality Assurance
**Country/Region**: Costa Rica
Job function summary
The Quality System Engineer supports Cartago site and that the Quality Management System is always in compliance with external and internal requirements. The QSE is monitoring, maintaining, and improving the quality system element (Veeva, TrackWise, STEP). As Local Process Owner, responsible for Coloplast main processes and ensure the translation / implementation / update of changes.
Major areas of accountability
- Ensure compliance with Coloplast Quality Management system in Cartago site
- Monitoring, maintaining, and improving the quality systems (Veeva, TrackWise, STEP, E1)
- Supervising, monitoring the Change Control database
- Change Request approver of product / process / machine changes or transfers
- In case any problem during approval process of CR responsible to initiate actions
- Local process owner of Change Control; CAPA; Non-conformity management; Audits; Veeva.
- As local process owner represents the site in process owner meetings and ensure that the changes of the procedures are implemented on time
- Support and active member in all internal and external audits
- Monthly reporting of local QA KPIs, follow up the trends and defined actions
- Weekly and monthly reporting from Quality systems (Veeva, TW, STEP, E1)
- Maintain and improve the document handling / archiving processes
- Support Head of Quality in data gathering and for Quality Management Reviews and making the MoM of QMRs
- Recommend and implement quality improvements of products/processes
- Contact with local departments and headquarter in Denmark
- Organize and make quality trainings (CAPA; NC; IA; Doc; CC)
- Supervising the document archiving system
- Controlling and supervising the drawing database
- Control of internal documents (stamps; printed documents in the production
- Performing their job in compliance with the guidelines given
- Drawing attention to the manager to any difficulties in understanding or following the guidelines
- Drawing attention to inefficiency of the system
- Take responsibility for those safety aspects identified for the given position
Responsible for
- Performing their job in compliance with the guidelines given
- Drawing attention to the manager to any difficulties in understanding or following the guidelines
- Drawing attention to inefficiency of the system
Essential qualifications
- Relevant technical academic background with bachelor’s degree or equivalent, or minimum 2 years of experience within medical device manufacturing
- Familiar with quality system standards ISO 13485, ISO 9001, MDSAP, MDD / MDR, 21CFR 820
- Related experience in medical device industry with thorough knowledge of methodologies of quality assurance and standards
- Excellent numerical skills and understanding of data analysis
- Good knowledge of MS Office and databases
- English B2 level reading, writing, and speaking in a conversational level
Preferred qualifications
- Microsoft office package, E1, TrackWise, SharePoint
Required knowledge, skills & abilities
- Functional Competences
- Quality Systems & Processes
- Statistical Analysis & Tools
- Technical Writing & Documentation
- Regulatory Landscape, Standards & Regulations
- System & Data Management
- Validation
- Design Control
- Cross Functional competencies
- Business Understanding
- Coloplast Products & Production
- Project Management
- Self-Management / People Development
- Decision-making
- Collaboration
- Communication
Why Coloplast?
Coloplast develops products and services that make life easier for people with personal and private medical conditions. Working closely with the people who use our products, we create solutions that are sensitive to their special needs. We call this Intimate healthcare.
We are guided by three values
**Closeness**: we work closely with our customers to find solutions that meet their specific needs.
**Passion**: we work passionately to create new and innovative products that improve the quality of life for our customers.
**Respect**: and responsibility we have deep respect for the private nature of the condition our customers face.
Therefore, it’s our responsibility to find not only medical solutions, but also ways to minimize the trauma and taboo associated with these conditions.
Our business includes Ostomy Care, Continence Care, Urology Care, and Wound and Skin Care
Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 14.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.
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