Quality Application Specialist

MG STAFFING GROUP•Villalba, PR

About The Position

The Quality Application Specialist supports quality, compliance, corrective action, and validation activities in the medical device industry. The role focuses on Field Corrective Actions (FCA), CAPA, product quality management, and validation of quality information technology systems, while helping maintain compliant quality systems and advance continuous improvement. The specialist works cross-functionally with Quality, Engineering, IT, developers, system users, and other stakeholders; monitors regulatory requirements and audit expectations; and provides guidance and technical support to other professionals as needed.

Requirements

Minimum 2 years of relevant experience in the medical device or regulated industry.
Experience in Field Corrective Actions (FCA), CAPA, or Product Quality Management.
Completed bachelor’s degree in Science or Engineering.
Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR, and applicable medical device regulations.
Experience leading or supporting FCA and CAPA processes.
Strong root-cause analysis, problem-solving, and analytical skills.
Strong project management skills, including the ability to manage multiple priorities and deadlines.
Excellent technical writing skills.
Strong communication and interpersonal skills, including the ability to work effectively with cross-functional teams.
Proficiency in Microsoft Office Suite and Quality Management Systems (QMS).

Nice To Haves

Equipment IQ experience.
OQ/PQ and Process Validation experience.
Knowledge of the Process Validation Lifecycle, from process characterization through OQ and PQ.
DOE using Minitab.
Computer System Validation (CSV).
SOP development.
Medical device Change Control experience.

Responsibilities

Lead and support FCA and CAPA processes, including investigations, root-cause analysis, corrective actions, and effectiveness activities.
Conduct compliant validation activities for quality information technology systems.
Prepare and maintain validation documentation and Standard Operating Procedures (SOPs) in accordance with applicable regulatory requirements.
Coordinate activities with Quality, Engineering, IT, developers, system users, and other stakeholders.
Identify current and anticipated compliance requirements and recommend appropriate procedures, actions, and documentation.
Monitor and report the status of validation and quality activities to support regulatory compliance.
Support system administration and configuration of quality information technology systems.
Evaluate quality issues and recommend improvements to systems and processes.
Manage assigned projects, priorities, milestones, and deadlines.
Maintain awareness of changing FDA and international regulatory requirements and audit expectations.
Provide guidance and technical support to other professionals as needed.
Perform other duties as assigned.