Senior Quality Engineer (Medical Devices) Trainer
A minimum of 2 years of experience in a quality role in a regulated industry such as medical device or pharmaceutical is preferred
- Knowledge in Process Validation: IQ/OQ/PQ/TMV.
- Capable to draft / maintain Master Validation Plans and strategies.
- Required experience with Gage R&R and Attribute Agreement Analysis.
- Experience with Minitab preferred.
- Experience with Validation preferred.
- Education in engineering preferred
Familiar with FDA Quality System Regulation, MDD, ISO 9001, ISO13485, and ISO 14971
- 21 CFR 820
- Utilize quality tools and techniques, lean six sigma, CAPA, root cause analysis, FMEA, non-conformance reporting, deviation investigations.
- Strong working knowledge of DMAIC \Six Sigma problem solving process. Belt certified a big plus.
- Utilize quality tools and techniques, lean six sigma, CAPA, root cause analysis, FMEA, non-conformance reporting, deviation investigations
Lead the investigation, resolution and prevention of product and process nonconformances and assigned corrective actions
Implement quality planning, control plan, FMEA, inspection methodology, and root cause analysis.
Participate in Material Review Board activities and feedback to suppliers.
Knowledge of Quality Engineering methodologies such as Design and Process Validation, Risk Management, Quality Systems, Continuous Improvement,
In-depth knowledge of quality systems and regulations for medical device industry.
Technical knowledge in development methodologies, design and project implementation, including, but not limited to GD&T, and DOE
Six Sigma Green Belt (Preferred)
Medical Device, CAPA, Quality, Root Cause, NCR, Change Control, Engineering, Quality Assurance, Risk Management
8 freelanceria on tarjonnut keskimäärin %project_bid_stats_avg_sub_18% %project_currencyDetails_sign_sub_19%/tunti tähän työhön
Hello, I have several years of experience in Medical Device industry in Design, FDA approval, CE marking, UL marking, etc. (ISO13485, ISO 14971,...etc implicit) Thanks and Regards, Sri Harsha