Overview
Quality Systems Specialist I Jobs in Alajuela, Costa Rica at Cirtec Medical
Title: Quality Systems Specialist I
Company: Cirtec Medical
Location: Alajuela, Costa Rica
Description
About us:
For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!
Position Summary:
Responsible for ensuring compliance to Cirtec Medical’s Quality Management System (QMS) requirements. As a shared corporate resource, this role contributes to standardization, continuous improvement, and operational excellence across all sites.
This role will work primarily with the administration, coordination, and maintenance of key QMS processes, including document control, records retention, microbiology data analysis and reporting, supplier quality compliance support, training system administration, quality metrics support, and quality system record maintenance.
Key Responsibilities:
Microbiology Support
- Support Microbiologists with collection, compilation, trending, analysis, and reporting of microbiological and environmental monitoring data.
- Support investigations related to microbiological excursions, contamination events, and adverse trends.
- Assist with gathering and organizing data related to bioburden, endotoxin, environmental monitoring, sterilization, and cleanroom monitoring activities.
- Maintain microbiology records in accordance with company procedures and regulatory requirements.
- Support validation and continuous improvement activities related to microbiological controls.
Document Control & Records Management Support
- Administer controlled documents within electronic Quality Management Systems.
- Process document revisions, approvals, releases, obsolescence activities, and document distribution.
- Coordinate archival and retrieval of quality records according to established retention requirements.
- Support Engineering Change Orders (ECOs) and document implementation activities as assigned.
- Ensure current approved documents are available and obsolete documents are removed from use.
Supplier Quality Support
- Support Supplier Quality Engineers and Quality Managers with maintaining supplier qualification and monitoring records.
- Assist in compiling supplier scorecards, supplier performance metrics, and supplier quality reports.
- Maintain supplier quality documentation including quality agreements, supplier assessments, supplier audits, approved supplier lists, and supplier corrective action records.
- Track supplier corrective action requests (SCARs) and assist with follow-up activities.
- Support supplier quality investigations and data collection activities.
- Assist with supplier audit preparation and audit record maintenance.
General Responsibilities
- Complies with company, quality and safety standards, policies, and procedures.
- Support CAPA activities, as necessary, driving corrections and corrective actions to successful completion.
- Provide support during internal audit and external audits.
- Consistently abide by and conforms to all established Cirtec Medical policies and procedures.
- Ensure adherence to training requirements regarding Quality Management System elements, controls, processes, and procedures.
- Support Corporate Quality Management System initiatives and continuous improvement activities.
- Adhere to professional workplace attire, time, attendance and leave of absence policies.
- Other duties as assigned.
Must Have:
- Associate’s or Bachelor’s Degree in Microbiology, Biological Sciences, Biotechnology, Life Sciences, Medical Laboratory Sciences, Engineering, Quality, or a related technical field required. Equivalent combinations of education, technical training, and directly transferable experience in regulated manufacturing environments may be considered. Microbiology or Life Sciences education is strongly preferred.
- Advanced Post-Secondary Education/Training/Certification coursework (Manufacturing or Engineering discipline preferred) preferred.
- Quality certification(s) (e.g., ASQ CQT, CQI, etc.) preferred.
- Class I, II and/or III Medical Device manufacturing experience preferred or other regulated manufacturing industry experience (e.g., Aerospace, Automotive, Defense, Pharmaceutical, etc.).
- Knowledge of, and experience with, GMP/ISO Standards.
- Must demonstrate ability and/or experience in computer use and general office software – Microsoft Office (i.e., Outlook, Word, Excel, and PowerPoint).
- “Hands-on” self-starter with ability to work both independently and as part of a team.
- Must be able to read, write and speak English.
Good to have:
- Experience with microbiological data analysis, environmental monitoring, or cleanroom operations.
- Experience with electronic QMS systems (MasterControl, Oracle, GoSaaS, ERP System, etc.).
- Experience maintaining supplier quality records and Approved Supplier Lists.
- Intermediate to advanced Microsoft Excel skills, including data analysis and trending.
Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job application process.
We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.
