Senior Quality Engineer (Medical Devices) Trainer

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)

CQE Certification

Technical skills

Medical Device, CAPA, Quality, Root Cause, NCR, Change Control, Engineering, Quality Assurance, Risk Management

Evner: Kemisk Ingeniørarbejde, Research Writing, SPSS Statistics, Statistisk analyse, Statistikker

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Om arbejdsgiveren:
( 0 bedømmelser ) United States

Projekt ID: #18914282

8 freelancere byder i gennemsnit $32/time for dette job


Hi,i would like to be considered for your writing project.I am a professional research writer with over 6 years of experience in providing high quality and plagiarism free work.I am well versed in evaluation of studie Flere

$100 USD / time
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Dear Sir/Madam, this is Humayun kabir here; I have Post graduation (Marketing & Management) from Liverpool John Moores University, United Kingdom. Also, I have got Postgraduate Diploma from Edexcel, UK on Management St Flere

$22 USD / time
(133 bedømmelser)

Hello I am pharmacist with 9 years experience in pharmaceutical industry in QC, QA and R&D. I am Certified Black Belt Lean Six Sigma from ASQ. I am Certified Quality Auditor from ASQ. I am Certified Manager of Quality Flere

$27 USD / time
(9 bedømmelser)

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

$27 USD / time
(1 bedømmelse)

Dear Client! Pharmacist here. I have read all your post, i have an experience of 1 year in pharmaceutical industry and i worked there as quality assurance officer and i was only concerned to the cGMP and GMP document Flere

$22 USD / time
(0 bedømmelser)

Dear sir, I am Tuan Tran in Vietnam, I have 12 year in Software Industry . I have experience in PHP (laravel, ci, yii ..)) , nodejs, angularjs, react (js and native), J2EE,and mobile applications. (android and iOS) Flere

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I have completed Six Sigma Master Black belt. I take six sigma freelance training/mentoring assignments.

$22 USD / time
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Dear Sir/Madam, I would like to apply for your Senior Quality Engineer (Medical Devices) Trainer project. I have an MBA degree with courses in ISO 9001, Lean Six Sigma, ISO 14001 (Environmental Management), OHSAS 18 Flere

$21 USD / time
(0 bedømmelser)