looking for Quality Engineer with FDA and CAPA exp in PA - 4 positions still open

Greetings from Sam from SourceChip, Inc

 

looking for Quality Engineer.

Please go through the below open position and let me know if you come across any match profiles.

 

Quality Engineer

Duration: 6 Months contract with possible extension

Location: Philadelphia, PA

Start date: ASAP

No of Positions: 05

Rate-$45/hr on w2 and $52/hr on c2c

 

Mandatory Skills:

Experience in product quality management- FMEA, FTA creation and update, Some Manufacturing Design/development experience, Mechanical background, complaint investigations, CAPA process, quality engineer activities for risk management, FDA regulations.

 

 

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

 

 

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.

 

Please respond with:-

Resume:

Availability:

Rate

Present Location:

Contact number No. with Email ID:

 

Regards,

 

Sam | SourceChip, Inc

sam@sourcechip.net 

28suman@gmail.com

PH - 732-917-4895

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