The Role
Lead and execute validation of quality IT systems and computer/software validation for medical devices. Coordinate with clients, developers, and operations; manage FCA/CAPA and process validation lifecycle (IQ/OQ/PQ); develop SOPs and change controls; report validation status and ensure compliance with FDA 21 CFR 820, ISO 13485, EU MDR; use QMS tools and DOE (Minitab) as needed.
Summary Generated by Built In
QUALITY CONSULTING GROUP, a leader in the 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:
Qualifications:
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
Skills Required
- Bachelor's degree in Engineering or Science
- 10+ years of experience in the medical device industry with strong background in field corrective actions, CAPA, or product quality management
- Solid understanding of FDA regulations (21 CFR Part 820), ISO 13485, EU MDR
- Proven experience leading FCA and CAPA processes
- Outstanding communication and interpersonal skills
- 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
- Knowledge of Process Validation Lifecycle (from process characterization through PQ)
- Preferred experience in DOE (with Minitab)
- Computer and software validation (CSV)
- SOP development
- Change control of medical devices
- Work 1st shift
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The Company
What We Do
The Quality Consulting Group is a pharmaceutical, biotechnology, food and medical device specialty consultant that supports the manufacturing industry; services are provided in multiple areas including: Regulatory Compliance, Quality Operations, Validation, Manufacturing, Training and Technical Support. Starting, as individual services provider since 2002, Quality Consulting Group has supported clients implementing the latest standards such as Validation Guidance, ICH Guidelines, and Process Excellence and Risk Management tools. Quality Consulting Group has provided expertise in such areas as: business, operational, quality, regulatory and manufacturing strategies; organizational structures; management controls; manufacturing and quality systems methodologies and practices; compliance programs; and accuracy reviews; FDA, EMEA and other regulatory matter
