mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Overview The Investigation / CAPA Specialists to support Quality Systems and Manufacturing Operations within a highly regulated medical device manufacturing environment. These resources will play a critical role supporting deviation investigations, nonconformance management, root cause analysis, CAPA development, and quality system compliance activities associated with manufacturing, engineering, and operational processes. The candidates will work cross-functionally with Manufacturing, Quality Assurance, Engineering, Supply Chain, and Operations teams to ensure timely closure of investigations and implementation of sustainable corrective and preventive actions aligned with FDA and ISO regulatory expectations.
Perform detailed root cause analysis using methodologies (such as…5 Whys, Fishbone / Ishikawa, Fault Tree Analysis, Risk Assessments, Trend Analysis …)
Ensure investigations are properly documented, technically justified, and closed within established timelines.
CAPA Management
Develop, implement, and track Corrective and Preventive Actions (CAPAs).
Evaluate CAPA effectiveness and sustainability.
Collaborate with cross-functional teams to ensure corrective actions address systemic issues.
Monitor CAPA metrics and identify recurring trends impacting quality performance.
Documentation & Compliance
Author and review investigation reports, CAPA records, technical assessments, and quality documentation.
Support documentation activities within electronic quality management systems (eQMS).
Ensure compliance
Support audit readiness initiatives and participate in internal/external audits.
Cross-Functional Collaboration
Partner with Manufacturing, Engineering, Validation, and Operations teams to evaluate process impact and implement corrective strategies.
Participate in risk assessments and continuous improvement initiatives.
Support escalation meetings and quality review boards when required.
Provide technical support during regulatory inspections and quality audits.
Required Qualifications
Bachelor’s Degree in: Engineering, Chemistry, Microbiology, Life Sciences, Industrial Sciences or Related Technical Discipline.
Minimum:
3 - 5 years of experience
Experience in Medical Device, Pharmaceutical, Biotechnology and FDA-regulated manufacturing environments.
Preferred Qualifications
Strong experience managing: Investigations, Deviations, Nonconformances and CAPA systems.
Hands-on experience with root cause analysis methodologies.
Experience using quality systems such as: TrackWise, Infinity, SAP, MasterControl, ETQ or Similar eQMS platforms.
Knowledge of: FDA regulations, ISO 13485, GMP requirements and Data Integrity principles.
Strong technical writing and documentation skills.
Experience supporting audit readiness and inspection support activities.
Key Technical Skills
Root Cause Analysis
CAPA Management
Investigation Writing
Nonconformance Management
Quality Systems
GMP Compliance
Risk Assessments
Technical Documentation
Problem Solving
Cross-Functional Coordination
Data Trending & Analysis
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.