The Role
Support medical device manufacturing through change control, equipment commissioning/qualification, process and computer system validation, packaging system design per ISO 11607 standards, troubleshooting, process improvements, investigations/root-cause analysis, and technical documentation across manufacturing, packaging, and lab equipment.
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:
- Change control of Medical Devices
- Equipment Commissioning / Qualification
- Process Validation
- Computer System Validation (CSV)
- Manufacturing, Packaging and Laboratory Equipment
- Technical experience (Trouble shooting) or any similar experience or background
- Quality / Process Control / Assurance of Medical Devices
- Design and development of a packaging system for terminally sterilized medical devices as per requirements established by ISO 11607-1 (Part 1: Requirements for materials, sterile barrier systems and packaging systems) and corresponding packaging ASTM and ISTA (International Safe Transit Association) standards.
- Validation of processes for packaging medical devices that are terminally sterilized as per requirements established by ISO 11607 2 (Part 2: Validation requirements for forming, sealing and assembly processes).
- These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.
Qualifications:
- Bachelor’s degree in Engineering
- 3+ years of relevant experience.
- Strong working knowledge of FDA Medical Devices Part 820 Quality System (QS) Regulation & Medical Device Good Manufacturing Practices
- Process Validation, Equipment IQ and Computer software validation knowledge
- Technical writing knowledge and Communication skills
- Investigation and root cause analysis skills
- Must have knowledge in Process Validation, Equipment IQ and Computer software validation.
- Provides technical and sustaining engineering support in a manufacturing area; therefore, investigation and root cause analysis skills are required to solve problems or improve effectiveness of job area (inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality).Good writing skills and communication skills in English and Spanish to have successful and productive meetings within a cross functional team
- Experiences with manufacturing processes creation / improvements
- Experience with process validations (IQ, PD, OQ, PQ)
- Special build coordination and follow up in manufacture.
- Shift: 1st shift and 2nd shift
Skills Required
- Bachelor's degree in Engineering
- 3+ years of relevant experience
- Working knowledge of FDA Medical Devices Part 820 Quality System Regulation and Medical Device GMP
- Process Validation experience (IQ, OQ, PQ)
- Equipment commissioning and qualification experience
- Computer System Validation (CSV) knowledge
- Design and development of packaging systems per ISO 11607-1 and ISO 11607-2
- Familiarity with ASTM and ISTA packaging/transportation standards
- Technical writing and strong communication skills
- Investigation and root cause analysis skills
- Experience with manufacturing process creation and improvements
- Special build coordination and follow-up in manufacturing
- Bilingual communication (English and Spanish) for cross-functional meetings
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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
