| Urgent Requirement || Validation Engineer || Middletown, PA || at Middletown, Pennsylvania, USA |
| Email: [email protected] |
| From: jatin parashar, Vyze Inc [email protected] Reply to: [email protected] Hi, I hope you are doing well, Job Description JOB TITLE : Quality Operations Manager/Validation Engineer Location: Middletown, PA, 17057 Onsite roles. Visa: Elkton, MD. Relocation will work. Interview Process: Skype Quality Operations manager with experience in Medical Device Operations Quality, CAPA, NCR, Root Cause, Statistical Background. Required Quality Manufacturing Operations experience; 10+ experience in Quality Operations and 5+ years management experience preferred. Qualifications/ Background Experiences Bachelors degree in science/math required. Minimum of 10 years Quality Assurance experience Minimum 5 years management experience Six Sigma/LEAN experience, expertise preferred. Must be proficient in Microsoft Excel, Word, PowerPoint, and Outlook Knowledge, Skills and Abilities (KSA) Knowledge of national and international regulations applicable to medical devices including Quality System Regulations, 21 CFR 820, 21CFR 803 and 804 (MDR regulations), Canadian Medical Device Regulations, ISO 14971, ISO 13485, and MDR etc., LEAN Prior experience in medical device manufacturing environment coupled with certifications from ASQ preferred. Ability to identify the strategic direction of the quality assurance system required. Ability to analyse and interpret all regulatory and quality guidelines as needed. Demonstrate a strong understanding and working knowledge of the Quality Sciences (Acceptance Sampling, SPC, continual improvement, Six Sigma, LEAN, Design of Experiments, COQ, Cause & Effect analysis etc.) Demonstrate a strong business partner approach and attitude providing creative and innovative solutions that meet quality standards. Jatin Parashar. Technical Recruiter E: [email protected] Keywords: Maryland Pennsylvania |
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| Tue Aug 22 02:13:00 UTC 2023 |