Fusion Plus Solutions Inc
Location
Secunderabad | India
Job description
Project Description min 50 words The R&D Quality engineers will be a part of the R&D Quality organization and deployed on R&D project teams to lead the quality engineering function on individual projects. The individual will be responsible for deploying system level SOP's and developing project level Quality plans and providing quality engineering support across the PDP phase
This role is responsible for all Design assurance related SOP's and documentation for the assigned projects and will provide inputs to the Quality Systems team to monitor and track all quality indicators. The individual will lead the Testing, Design and process.
That include the following activities from Customer location (Pune, India).
- Lead the quality engineering across the entire development cycle.
- Transition projects from Exploratory and Technology development (TDP) phase to product development phase (PDP)
- Develop and enforce Quality Plans in adherence to internal SOP's, global compliance norms and product and industry regulatory and safety requirements
- Design Assurance, Verification & Validation
- Co-lead the development of Critical to Quality (CTQ)'s, design input and output documents,.
- Lead the development and implementation of design verification and validation plans with project design lead.
- Lead the development and implementation of process verification and validation plans (IQ, OQ and PQ support)
- Participate and implement tools like Design of Experiments (DOE's), FMEA sessions, Risk Management and ensure compliance to CTQ's and safety requirements.
- Responsible for co-leading stage gate reviews and signatory on all PDP document approvals
- Manage electronic document control and version control on all project related documents.
- Implement the global electronic document management and design assurance systems at the R&D center.
- Ensure adherence to the quality systems and design assurance SOPs and client's PLCP.
- Lead reliability, testing and validation testing - internal and local vendors
- Provide statistical testing and reliability plans.
- Partner with process development engineers to design transfer to manufacturing.
- Quality Systems
- Participate in Quality system audits and provide necessary support.
- Participate in continuous improvement projects for quality systems.
- Develop and support CAPA plans.
- Participate in ISO certification for the R&D center
- Regulatory
- Provide guidance on regulatory compliance requirements for ISO, client guidelines and external market and global guidelines i.e. MDD, FDA, QSR etc.
- Work closely with regulatory team to drive alignment of project documentation and regulatory requirements.
Skills/Experience Required - Medical Devices (Class II & III). R&D Quality engineering
- Experienced in quality systems and / or quality engineering supporting R&D projects, design assurance and documentation
- Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control and CAPA management.
- Certification as an Internal Quality Auditor will be preferred.
- Sound understanding of medical device regulatory requirements for Class II and III medical devices.
- Proficient in project management tools like MS project.
- Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis).
- Past experience as a design engineer will be an added advantage.
- Project planning - resourcing, timelines, quality and budgets.
- Experienced in Process based work culture
Tools proficiency - Well versed with CAD & CAM tools on platforms like Solidworks
- Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB
- MS office, MS Project
Academic Qualification And Experience - Bachelors (or higher) degree in engineering or life sciences with preference Mechanical engineering, electronics and embedded systems , plastics and polymer engineering and biomedical engineering.
- 5 - 8 years of experience in medical device R&D Quality engineering
- Certification as an Internal Quality Auditor will be preferred.
- Certification in Quality Management Systems including ISO 13485, Risk management ISO 14971 will be preferred
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