JT678 - QUALITY APPLICATIONS SPECIALISTS

Quality Consulting Group, LLC; Puerto Rico; On-site; USD 120,000 - 160,000; Full time

Job summary

QUALITY CONSULTING GROUP, LLC is seeking a talented Quality Engineer to join our team in Puerto Rico and the USA, focusing on compliant validation of IT systems and medical device regulations. You will coordinate with clients and cross-functional teams, lead FCA, CAPA, and documentation under FDA and international standards, and stay current with regulatory changes.

This role requires a Bachelor's in engineering or science and 10+ years in medical devices, with strong technical writing and

Qualifications

• Bachelor’s degree in Engineering or Science.
• 10+ years in the medical device quality/regulatory field.
• Experience leading FCA and CAPA processes.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, EU MDR.
• Excellent written and verbal communication.

Responsibilities

• Conducts a compliant validation process for IT systems under federal regulations.
• Coordinates activities with clients, developers and personnel, domestic and global.
• Identifies requirements and maintains procedures to ensure regulatory compliance.
• Reports on validation status to fulfill regulatory requirements.
• Keeps abreast of changing federal and international regulatory requirements.

Skills

FDA regulations

CAPA

QMS

Cross-functional collaboration

Technical writing

DOE (with Minitab)

Software validation

IQ/OQ/PQ

Process validation lifecycle

SOP development

Change control

Education

Bachelor’s degree in Engineering or Science

Tools

Minitab

QMS software

Microsoft Office

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities

• Conducts a compliant validation process for quality information technology systems which requires formal validation documentation (including standard operating procedures) under appropriate federal regulations.
• 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 for the identification, implementation and maintenance of the procedures, actions and documentation necessary to assure compliance according to the appropriate federal and international regulations which govern the user's applications.
• 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.

Qualifications

• Bachelor’s degree in Engineer or Science
• 10+ years of experience in the medical device industry, with a strong background in field corrective actions, CAPA, or product quality management. 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.
• Outstanding communication and interpersonal skills, capable of effectively working with cross-functional teams and external stakeholders.
• Proficiency in Microsoft Office Suite and quality management systems (QMS). Strong technical writing capability
• Experience in equipment IQ
• Experience in OQ (Operational Qualification) and PQ (Performance Qualification) and/or process validation
• Process Validation Lifecylce ( from process characterization, operational qualification to performance qualification)
• Preferred experience in DOE (with minitab)
• Computer and software validation CSV
• SOP Development
• Change control of Medical Devices
• 1st shift

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.