Need Quality Engineer (QE)@ PA

Dear,                                               

 We currently have an opportunity for a Quality Engineer (QA) with a major company located in PA.          .     

 

Job Title	:	Quality Engineer (QE)
Location	:	Philadelphia, PA
Duration	:	9 – 12 Months contract
Job Description	:	·         Lead quality engineer activities for risk management, as it relates to design and development, complaint investigations, and non-conforming materials. ·         Ensure high level of compliance to FDA QSR and ISO 13485 in all assigned areas ·         Work closely with internal departments (Operations, Advanced Operations and Research & Development) to provide risk assessments as required ·         Participate in project teams with internal departs to support product and/or process design and development activities ·         Perform literature review and analysis to support FDA submissions, utilizing medical knowledge and experience ·         Support the NC/CAPA process with risk assessments   Mandatory Skills: Some Manufacturing Design/development experience , Mechanical background, complaint investigations , CAPA process ,quality engineer activities for risk management, FDA regulations.   Qualifications/Work Experience . Minimum of three years working in medical or clinical setting, such as a registered nurse, preclinical RN, clinical affairs . Demonstrate the applied knowledge of FDA and/or International medical device regulations . Demonstrate the ability to work effectively in cross functional teams . Demonstrate problem solving and troubleshooting skills . Demonstrate interpersonal and communication skills . Demonstrate ability to exhibit a positive, energetic approach to teamwork . Demonstrate ability to advocate product excellence and quality . Demonstrate ability to respond to urgent needs of the team, with proven track record of meeting deadlines . Proficient utilizing computers, including Microsoft suite, Outlook and Adobe   Education: Bachelor's Degree in a life science/medical related field of study.
Additional Notes:	:

 

 Send the resume to Manideep@pullskill.com Along with the contact details

 

 

Thanks & Regards :

Manideep | Pull Skill Technologies Inc. | IT Recruiter

Office: 201-484-7871| Fax: 201-641-0110 | Email:Manideep@pullskill.com

393 Farview Ave ∙ Paramus, NJ-07652.

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