[4025MSCRMCV] urgently required quality engineer

Quality Engineer

Duration: 9 – 12 Months contract

Location: Philadelphia, PA

Start date: ASAP

 

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.

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Thanks & Regards
Ankur Bhatia
E : ankurhmg@gmail.com

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