Quality Application Specialist

MG STAFFING GROUP•Villalba, PR

66d•Onsite

About The Position

The Quality Application Specialist supports quality and product transfer activities within a regulated medical device manufacturing environment, with primary responsibility for process validation and product commercialization efforts. This role ensures compliance of quality systems, manufacturing processes, and computerized systems with applicable FDA and international regulatory requirements.

Requirements

Bachelor's Degree in Engineering, Science, or a related technical discipline.
3 to 6 years of experience in Medical Device, Pharmaceutical, Biotechnology, or other FDA-regulated industries.
Knowledge of Sterilization processes and validation requirements.
Knowledge of Final Packaging operations and associated quality requirements.
Process Validation lifecycle experience.
Statistical Analysis and data interpretation.
Process Failure Mode and Effects Analysis (PFMEA).
First Time Quality methodologies and quality improvement initiatives.
Validation documentation development and execution.
Root Cause Analysis and problem-solving techniques.
Good Manufacturing Practices (GMP) and quality system regulations.

Nice To Haves

Experience supporting product transfer and commercialization activities preferred.
Computer System Validation (CSV).
Risk Management methodologies.
CAPA, Change Control, and Investigation management.
Technical writing and documentation development.
Experience with regulated quality systems and computerized applications.
Strong analytical and problem-solving skills.
Excellent verbal and written communication skills.
Ability to manage multiple projects and priorities simultaneously.
Strong collaboration and cross-functional teamwork skills.
Ability to work independently with minimal supervision while delivering project objectives.

Responsibilities

Support product transfer activities from development through commercial release.
Execute and maintain process validation lifecycle activities, including protocol development, execution, analysis, and reporting.
Conduct validation activities for quality information technology systems, ensuring compliance with applicable regulatory requirements.
Develop, review, and maintain validation documentation, including SOPs, validation plans, protocols, reports, and supporting records.
Support sterilization processes and validation activities to ensure compliance with established standards and product requirements.
Provide quality oversight for final packaging operations and associated validation requirements.
Perform statistical analysis to evaluate process performance, capability, and validation results.
Lead or support Process Failure Mode and Effects Analysis (PFMEA) activities to identify and mitigate process risks.
Drive First Time Quality initiatives through data analysis, root cause investigations, and continuous improvement efforts.
Coordinate activities with cross-functional teams including Manufacturing, Quality, Engineering, Regulatory Affairs, Operations, and external partners.
Support system administration and configuration of quality-related computerized systems as required.
Monitor and report validation project status to ensure regulatory and business objectives are met.
Stay current with FDA regulations, international standards, industry best practices, and quality system requirements.
Identify opportunities for process improvements and recommend enhancements to improve efficiency, compliance, and product quality.
May provide guidance and mentoring to junior team members and support personnel.