Qa Design Transfer Engineer I/ii - Pearland, Tx

992

Pearland, TX, US
Not specified; not specified; benefits: medical/de...
Onsite
Bachelor's degree in engineering
21 cfr 820 quality systems knowledge
Iso 13485 regulatory standards
The role involves guiding the design team through Process Validation, Test Method Validation, and Device Master Record creation to ensure outputs are transferred into manufacturing

Job Summary

  • The role involves guiding the design team through Process Validation, Test Method Validation, and Device Master Record creation to ensure outputs are transferred into manufacturing.
  • Candidates must coordinate process risk analysis activities, lead risk management meetings, and facilitate improvements to mitigate risks effectively.
  • Merit Medical offers a comprehensive benefits package including medical/dental insurance, onsite clinics, cafeterias, and a 401K plan with health savings accounts.

Matching Summary

The role involves guiding the design team through Process Validation, Test Method Validation, and Device Master Record creation to ensure outputs are transferred into manufacturing.

Salary

Not specified; Not specified; Benefits: Medical/Dental, 401K, Paid Holidays, Vacation

Skills & Requirements

Must-have

  • Bachelor's Degree in Engineering
  • 21 CFR 820 Quality Systems knowledge
  • ISO 13485 regulatory standards
  • Process Validation and Test Method Validation
  • Root cause investigation and corrective actions
  • Engineering Change Notification (ECN) management

Nice-to-have

  • Minitab statistical software experience
  • Oracle database familiarity
  • ASQ Certified Quality Engineering exam
  • Lean manufacturing and Six Sigma methodologies
  • Mentoring engineers and technicians
  • Continuous improvement techniques

Key Requirements

  • Bachelor's Degree in Engineering or related field
  • Working knowledge of ISO 14791 and medical device regulations
  • Demonstrated computer skills in spreadsheets and databases
  • Experience with statistical methodologies and project management
  • Passed ASQ Certified Quality Engineering exam (Preferred)

Work Rights

Not specified

Tailored Resume

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