Sr. Quality Applications Specialist

Marc Jacobs International, LLC; Villalba (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

Marc Jacobs International, LLC seeks a seasoned QA/Validation professional to lead validation of quality IT systems, including IQ/OQ/PQ, computer and software validation, SOP development, and change control. You will coordinate with clients, developers, and operations across domestic and international sites to ensure regulatory readiness.

The role emphasizes FCA/CAPA processes, adherence to 21 CFR Part 820, ISO 13485, and EU MDR with a risk-based approach to validation and process improvements.

Qualifications

• Bachelor's degree in Engineering or Science required.
• 8 years of exposure in Medical Devices industry with CAPA/CF mapping.
• Bilingual: Spanish and English.
• Strong teamwork and cross-functional collaboration skills.

Responsibilities

• Conducts a compliant validation process for quality IT systems with formal documentation.
• Coordinates activities with clients, programmers/developers, and operating personnel domestically and internationally.
• Identifies requirements for compliant computerized operations and supports procedures implementation and maintenance.
• Reports on validation status to fulfill regulatory requirements.
• Keeps abreast of FDA and international regulatory requirements and audit policies.

Skills

Bilingual Spanish and English

Teamwork

Problem-solving

Communication

Regulatory awareness

Education

Bachelor's Degree in Engineering or Science

Tools

IQ/OQ/PQ

DOE

Validation Software

SOP Development

Job description

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!

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