Quality Engineer (Product Quality , CAPA, Risk management)
HCL Technologies - Mid City East, PA

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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

Bachelor's Degree in a life science/medical related field of study.

Monster - 17 months ago - save job
About this company
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HCL Technologies is an IT Services company headquartered in Noida, India. They provide a variety of IT and BPO services globally. According...