QMS and PLM Engineer

Department:
Quality

Location:
CRI-Costa Rica-Belen

Description
Role summaryThis position is ideal for experienced professionals with strong QMS and PLM expertise to join the Global QMS team as a QMS and PLM Engineer. You will support the harmonization of quality processes across regions, optimize system configurations and enable data-driven decision-making. Partnering with cross-functional teams to ensure our global QMS is not only compliant but also agile, scalable, and digitally empowered to ensure alignment with corporate standards and support regulatory readiness across the organization. This role helps create standardized and consistent quality processes within Align QMS, supporting the success of the business.

Role expectations

• Improve and assess PLM system configurations (such as Arena PLM or similar electronic QMS tool) to ensure alignment with global QMS processes.
• Develop and maintain workflows, templates, access permissions, and system documentation to support QMS areas including, but not limited to, Change Management, CAPA, NC, Internal Audits, using QMS electronic tool (e.g. Arena PLM).
• Manage user roles and system functionality to support quality processes across the organization.
• Contribute to global harmonization by reviewing site-specific QMS procedures and aligning them with corporate standards.
• Create and maintain standardized documentation, procedures, and templates to ensure traceability and compliance with internal policies and external regulations.
• Support training efforts for QMS and PLM processes, and assist in change management activities, including communication and rollout of new or revised procedures.
• Collaborate with quality leads, process owners, and stakeholders across functions and geographies to ensure consistent implementation of QMS and PLM practices.
• Participate in internal audits and support external regulatory inspections by ensuring system readiness and data integrity.
• Support global CAPA and NC processes by investigating issues using root cause analysis techniques, developing effective corrective and preventive actions, monitoring implementation and verifying results.

What We're Looking For

• Bachelor's degree in Engineering, Quality, Information Technology, Industrial Engineering or a related field.
• 5-7 years of experience working with QMS and electronic QMS tools within the medical device industry. Experience with Arena PLM is considered an advantage.
• Practical expertise with platforms such as Arena PLM (preferred) and Agile, and strong technical knowledge of QMS electronic tools.
• Proficiency in English (minimum B2+).
• Solid understanding of regulatory requirements including ISO 13485, FDA 21 CFR Part 820, MDSAP, and EU MDR.
• Proven experience creating and updating procedures, leading CAPA investigations, performing root cause analysis and training others on quality processes.
• Excellent presentation and communication skills, with a track record of working effectively with cross-regional stakeholders.
• Ability to work independently and collaborate with global teams and colleagues from diverse backgrounds and cultures, showing respect, adaptability, and a commitment to building a strong quality culture.

Complementary Skills

• Proficiency in Microsoft Office tools (Excel, Word, PowerPoint).
• Ability to work flexible hours to support collaboration across APAC, EMEA, and Americas regions.
• Creative thinking to make quality engaging for everyone and inspire a culture where every team member is a champion for quality.

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Equal Opportunity Statement
Align Technology is an equal opportunity employer. We are committed to providing equal employment opportunities in all our practices, without regard to race, color, religion, sex, national origin, ancestry, marital status, protected veteran status, age, disability, sexual orientation, gender identity or expression, or any other legally protected category. Applicants must be legally authorized to work in the country for which they are applying, and employment eligibility will be verified as a condition of hire.