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:
- Responsibility in our technical functions to advance existing technology or introduce new technology and therapies.
- Formulates, delivers and/or manages projects assigned and works with other stakeholders to achieve desired results.
- May act as a mentor to colleagues or may direct the work of other lower level professionals.
- The majority of time is spent delivering R&D, systems or initiatives related to new technologies or therapies – from design to implementation - while adhering to policies, using specialized knowledge and skills.
- Develops and applies computer aided design (CAD) software engineering methods, theories and research techniques in the investigation and solution of technical problems.
- Assessing architecture and hardware limitations, plans technical projects in the design and development of CAD software.
- Defines and selects new approaches and implementation of CAD software engineering applications and design specifications and parameters.
- Develops routines and utility programs.
- Prepares design specifications, analysis and recommendations for presentation and approval.
- May specify materials, equipment and supplies required for completion of projects and may evaluate vendor capabilities to provide required products or services.
Qualifications:
- Bachelor Degree in Engineering.
- Four (4) year of previous experience in Medical Device or Pharmaceutical Industry.
- Experience in Equipment validation, FDA Compliance and Statistical Analysis
- Problems and issues faced are general and may require understanding of broader set of issues or other job areas but typically are not complex.
- Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
- Available for 1st shift
Top Skills
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
