{SAP JOBS USA:117146} Requirement for Senior Quality Engineer

anil@hmgamerica.com

Contact No. 7326451532

Hi,

Hope you are doing Great

Senior Quality Engineer

Duration: 9 – 12 Months contract

Location: Philadelphia, PA

Experience level: 8 years plus

 

Please have candidate fill below skill set matrix without fail.

 

Mandatory Skills	No of years of experience	Last used year
CAPA (End to End process ,from initial to end)
Product quality management activities
Complaint investigations
Risk management
FMEA, FTA etc.
Medical Device industry experience

 

 

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 , Medical device industry, 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.

THANKS

REGARDS

ANIL DHIMAN

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