Senior Quality Systems & Validation Specialist

FITS, LLC; Villalba (PR); On-site; USD 95,000 - 130,000; Full time

Job summary

FITS, LLC in Puerto Rico is seeking an experienced Validation Engineer to support quality IT systems validation and regulatory compliance in the medical device sector.

The role requires a Bachelor’s degree in Engineering or Science, 8 years in medical devices, strong teamwork, and bilingual Spanish/English. Experience with IQ/OQ/PQ, DOE, CAPA, FCA, and FDA/ISO standards is essential for success.

Qualifications

• Bachelor’s degree in Engineering or Science with 8 years in Medical Devices.
• Bilingual in Spanish and English.
• Experience in CAPA or FCA.
• Strong understanding of IQ/OQ/PQ and process validation.
• Knowledge of DOE and regulatory requirements.

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 skills

CAPA experience

FCA leadership

Medical device validation experience

FDA/ISO compliance knowledge

DOE experience

IQ/OQ/PQ experience

Process validation lifecycle

Education

Bachelor’s degree in Engineering or Science

Tools

SOP Development

Change control of Medical Devices

Computer and software validation

Job description

FITS, LLC in Puerto Rico is seeking an experienced Validation Engineer to support quality IT systems validation and regulatory compliance in the medical device sector.

The role requires a Bachelor’s degree in Engineering or Science, 8 years in medical devices, strong teamwork, and bilingual Spanish/English. Experience with IQ/OQ/PQ, DOE, CAPA, FCA, and FDA/ISO standards is essential for success.