Sr. Quality Applications Specialist

Flexible & Integrated Technical Services, LLC•Villalba, PR

4d•Onsite

About The Position

This role is for Engineering services in the Manufacturing area, focusing on quality applications within the Medical Devices Industry. The position requires a strong background in field corrective actions, CAPA, or product quality management. The ideal candidate will be bilingual in Spanish and English, possess excellent teamwork skills, and be adaptable to business needs regarding shift work. The role involves conducting compliant validation processes for quality information technology systems, coordinating activities with various stakeholders, and staying updated on regulatory requirements. Additionally, it includes performing system administration, supporting product transfer activities with a focus on sterilization machines, validation, and process, and applying knowledge of process failure mode analysis and first-time quality. A solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations is essential. The position also requires strong project management, problem-solving, analytical, communication, and interpersonal skills, along with proficiency in quality management systems and technical writing.

Requirements

Bachelor’s Degree in Engineering or Science
Eight (8) years of exposure within the Medical Devices Industry
Strong background in field corrective actions, CAPA, or product quality management
Bilingual: Spanish and English
Excellent teamwork skills
Experience in equipment IQ, OQ, and PQ and/or process validation.
Experience in Process Validation Lifecycle.
Computer and software validation, SOP Development, Change control of Medical Devices
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
Proficiency in quality management systems.
Strong technical writing capability.

Nice To Haves

Preferred experience in DOE.

Responsibilities

Conducts a compliant validation process for quality information technology systems, which requires formal validation documentation.
Coordinates activities with clients, programmers/developers, and operating personnel, domestic and, as appropriate, global.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods to identify, implement, and maintain the procedures.
Reports on the status of validation activities to fulfill regulatory requirements.
Keeps abreast of changing federal and international regulatory requirements, government audit policies, and the availability of current techniques.
Performs system administration and configuration of quality information technology systems.
Quality role to support product transfer activities, focus on sterilization machines, validation, and process.
Experience with process failure mode analysis and first-time quality.
Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR, and other relevant medical device regulations.
Proven experience leading FCA and CAPA processes, ideally within a medical device or regulated industry.
Strong project management skills, with the ability to manage multiple priorities and deadlines.
Excellent problem-solving and analytical skills, with the ability to identify root causes and implement effective corrective actions.
Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
Proficiency in quality management systems.
Strong technical writing capability.