Sr. Quality Applications Specialist

FITS LLC; Villalba (PR); On-site; USD 80,000 - 110,000; Full time

Job summary

FITS LLC seeks an experienced Quality Assurance professional to lead validation and CAPA activities in medical device environments. This role focuses on IQ/OQ/PQ, DOE, and compliant validation of quality IT systems, working with cross-functional teams in the US and internationally.

You will collaborate with clients, developers, and operations, ensure regulatory compliance (FDA 21 CFR 820, ISO 13485, EU MDR), and drive continuous improvement through robust documentation and problem-solving.

Qualifications

• Bachelor's degree in Engineering or Science with eight years in Medical Devices industry.
• Bilingual in Spanish and English.
• Experience in field corrective actions, CAPA, or product quality management.
• Shift: 1st shift.

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.

Skills

Bilingual: Spanish and English

Teamwork

Project management

Analytical/problem-solving

Technical writing

Education

Bachelor's Degree in Engineering or Science

Job description

For Engineering services in the Manufacturing area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering or Science and eight (8) years of exposurewithin the Medical Devices Industry,with a strong background in field corrective actions, CAPA, or product quality management.
• Bilingual: Spanish and English
• Soft Skills: Excellent teamwork skills
• Shift: 1st, and according to business needs.
• Experience in:
  • Experience in equipment IQ, OQ, and PQ and/or process validation.
  • Process Validation Lifecycle.
  • Preferred experience in DOE.
  • Computer and software validation, SOP Development, Change control of Medical Devices

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one of your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)

• 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.
  

WHO WE ARE:

We are a Service Provider company, different from the rest. We pride ourselves on how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities, and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented, and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device, and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?