URGENT -Quality Engineer with risk management, FDA regulations-Healthcare experience Required

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

 

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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