Job Description

PTC INTEGRITY ALM AND APM
5.00 to 25.00 Years
10
BENGALURU [India]
IT
22/01/2019
19/04/2019
¿ Bachelors (or higher) degree in engineering with preference mechanical engineering. ¿ 3 5 years of experience in medical device R&D quality engineering, systems and / or quality engineering supporting R&D projects, design assurance ¿ Professional training and certification in in Quality Management Systems including ISO 13485, Risk management ISO 14971, design assurance / control, verification and validation. ¿ Sound understanding of medical device regulatory requirements for Class II and III medical devices. ¿ Project planning ¿ resourcing, timelines, quality and budgets.¿ Skilled in implementing Quality tools like design of six sigma, risk management, FMEA, FTA (Fault Tree Analysis). ¿ Preference for candidates with CQE certification or similar training and experience ¿ Proficient in project management tools like MS project.¿ Experience in GD&T¿ Well versed with statistical analytical techniques and s/w tools like MATLAB, MINITAB.¿ Ensure appropriate Project/Sustaining Quality Deliverables are created and properly executed (e.g. Project Design & Development Plan, Risk Management Plan, Hazard Analysis, Use and Design FMEA, Field Assessment Plan, and Software Validation Plan if applicable).¿ Co Lead CAPA efforts, and apply sound, systematic problem solving methodologies identifying, prioritizing, communicating and driving resolution of quality issues (e.g., 5 why¿s analysis, Is Is Not analysis, and Six Sigma problem solving methodologies).¿ Devise and support the implementation of effective quality assurance, process controls, statistical analyses, and metrics that assure products meet or exceed internal quality as well as statutory requirements.¿ Participate in ISO13485 site certification for the R&D center.Quality System Engineer:¿ Bachelors (or higher) degree in engineering or life sciences preferably in mechanical engineering, electronics and embedded systems, plastics and polymer engineering or biomedical engineering. ¿ 3+ years of experience in medical device   in quality systems and / or quality assurance.  ¿ Preference for candidates with PMP certification or similar project management training and experience. ¿ Professional training and certification in in Quality Management Systems including ISO 13485, 21 CFR 820, 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 MS Office.¿ Experienced in process based work culture.