Overview
We are seeking a Quality Engineer - NPI & Tech Transfer to support the introduction of new products and seamless transfer of manufacturing processes into production. The successful candidate will work cross-functionally with R&D, Operations, Engineering, and suppliers to ensure that quality is embedded in every phase of product development and launch. This role will play a critical part in process validation, risk management, and ensuring compliance with regulatory and industry standards.
Key Responsibilities:
- Provide quality support for NPI projects, ensuring that new products meet all regulatory and quality requirements before commercialization.
- Act as a key quality representative in technology transfer projects, collaborating with R&D, manufacturing sites, and suppliers to ensure smooth transitions.
- Support the design transfer process, ensuring design intent is effectively translated into robust manufacturing processes.
- Drive process validation (IQ/OQ/PQ) activities for new products and transferred processes.
- Identify and mitigate risks using Failure Mode and Effects Analysis (FMEA) and other risk management tools.
- Review and approve process development documentation, including validation protocols, reports, and control strategies.
- Lead or support non-conformance investigations (NCs), Corrective and Preventive Actions (CAPAs), and process improvements related to new product launches.
- Ensure regulatory and compliance requirements are met for new products and transferred technologies, aligning with ISO 13485, FDA, and GMP guidelines.
- Support supplier quality activities, ensuring that raw materials, components, and manufacturing partners meet quality requirements.
- Develop and track quality metrics (KPIs) related to NPI and tech transfer, analyzing trends and implementing proactive improvements.
- Provide input on design for manufacturability (DFM) and work with R&D and Engineering to ensure seamless scale-up.
- Participate in internal and supplier audits to assess readiness for production and compliance with quality standards.
- Collaborate with cross-functional teams to drive continuous improvement initiatives in manufacturing processes.
- Provide training and guidance on quality requirements for NPI and tech transfer to relevant stakeholders.
Required Qualifications & Skills:
- Bachelor's degree in Engineering, Science, or a related discipline (or equivalent experience).
- Experience in New Product Introduction (NPI), technology transfer, or process validation within a regulated industry (e.g., medical devices, pharmaceuticals, or manufacturing).
- Strong knowledge of Quality Systems, Risk Management (FMEA), CAPA, and Change Control.
- Hands-on experience with process validation (IQ/OQ/PQ), supplier quality management, and manufacturing scale-up.
- Ability to manage multiple projects simultaneously in a fast-paced, cross-functional environment.
- Strong problem-solving skills with the ability to analyze and interpret data for decision-making.
- Proficiency in Microsoft Office Suite, statistical analysis tools, and quality management systems (QMS).
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- Willingness to travel as required.
Preferred Experience:
- Experience with ISO 13485, FDA regulations, GMP, and medical device/pharmaceutical industry requirements.
- Familiarity with statistical process control (SPC), Six Sigma methodologies, and Lean Manufacturing principles.
- Experience working with contract manufacturers and global supply chains.
