Quality Engineer

3 weeks ago

Austin, United States Intellectt Inc Full time

Job Title: Quality Engineer

Location: Austin, TX

Duration: 12 Months

Shift Timings: 9 AM – 5 PM


Job Description:

We are seeking an experienced Quality Engineer to join our team for a medical device client. In this role, you will ensure the highest standards of product quality and compliance with industry regulations. You will be integral to ensuring that all medical devices meet regulatory and customer requirements while supporting continuous improvement initiatives across the product lifecycle.


Key responsibilities include:

  • Leading quality activities in the design, development, and manufacturing of medical devices.
  • Supporting root cause analysis (RCA), corrective and preventive actions (CAPA), and non-conformance reports (NCR).
  • Conducting verification and validation activities (IQ, OQ, PQ, MSA), process validation, and regulatory submissions.
  • Driving continuous improvement initiatives using Lean, Six Sigma, and other quality tools.
  • Ensuring compliance with ISO 13485, FDA, and other relevant regulations.
  • Supporting Design for Manufacturability (DFM) and Design for Assembly (DFA) to improve product quality.
  • Leading Failure Mode Effects Analysis (FMEA) and managing risk assessments.
  • Conducting internal and external audits to ensure regulatory and quality system compliance.
  • Collaborating with cross-functional teams, including R&D, Manufacturing, Regulatory Affairs, and Supply Chain.


Qualifications:

  • Bachelor’s degree in Quality Engineering, Mechanical Engineering, or a related field.
  • 3+ years of experience in quality engineering, preferably in the medical device or regulated industries.
  • Strong knowledge of ISO 13485, FDA regulations, and quality system requirements.
  • Proficiency in quality tools such as SPC, RCA, FMEA, CAPA, and DOE.
  • Ability to work cross-functionally and influence teams to drive quality initiatives.
  • Strong communication skills, both written and verbal.
  • Detail-oriented with strong problem-solving and analytical skills.

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