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:
- Provides technical and sustaining engineering support within a manufacturing environment.
- Recommends and implements equipment and process modifications to improve quality, production efficiency, manufacturing techniques, and product yields.
- Integrates equipment and material capabilities to meet process and technology specifications.
- Reviews product development requirements to ensure compatibility with manufacturing and processing methods.
- Collaborates with Product Design and Development teams to ensure product designs are compatible with manufacturing processes.
- Conducts or supports statistical analysis and uses data to evaluate and improve manufacturing processes.
- Leads the development, innovation, and optimization of new manufacturing processes and procedures.
- Supports process transfer to manufacturing operations.
- Performs feasibility studies and scouting for new manufacturing concepts, materials, processes, and equipment.
- Supports material selection, process selection, equipment selection, and tooling/fixture selection.
- Supports equipment and tooling installation and evaluates process inputs, outputs, and alignment with requirements.
- Develops manufacturing processes compatible with Statistical Process Control (SPC).
- Develops or supports measurement systems for manufacturing processes.
- Ensures manufacturing processes and procedures comply with regulatory and quality requirements.
- Manages assigned engineering projects and works with cross-functional stakeholders to achieve project objectives.
- Works independently under general supervision on moderately complex projects and assignments.
- Contributes to project milestones and participates in cross-functional engineering assignments.
- Bachelor's degree in Engineering
- 2+ years of relevant experience
- Manufacturing/process engineering experience
- Technical/sustaining engineering support in a manufacturing environment
- Process improvement and optimization
- Equipment/process modifications
- Yield and production efficiency improvement
- Ability to work with product/design development teams
- Understanding of manufacturing methods and process requirements
- Statistical analysis / process control
- Compliance with regulations and procedures
- Ability to work independently with general supervision
Skills Required
- Bachelor's degree in Engineering
- 2+ years of relevant experience
- Manufacturing or process engineering experience
- Technical or sustaining engineering support in a manufacturing environment
- Process improvement and optimization experience
- Experience with equipment and process modifications
- Experience improving yield and production efficiency
- Ability to work with product design and development teams
- Understanding of manufacturing methods and process requirements
- Statistical analysis and process control knowledge
- Knowledge of regulatory and procedural compliance
- Ability to work independently under general supervision
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
