Sr. Design Quality Engineering

Simarn Solutions

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profile Job Location:

Irvine, CA - USA

profile Monthly Salary: Not Disclosed
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

Sr. Design Quality Engineering
Location: Irvine California
Job Type: C2C Hybrid
Pay Rate: $50/hr
Industry: Manufacturing / Medical Devices
End Date: 01-Jan-2026

Job Description

We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance supporting risk management activities and leading verification and validation processes. The role requires strong collaboration with cross-functional teams hands-on involvement in design control and the ability to resolve quality issues through structured problem-solving and risk-based approaches.

Responsibilities

  • Ensure quality engineering activities meet regulatory and internal standards.
  • Create and maintain product risk management documentation (Risk Plans DFMEA Risk Assessments Risk Reports).
  • Support development and execution of V&V plans protocols and reports.
  • Perform Test Method Validation and process validation (PFMEA IQ OQ PQ).
  • Use statistical tools such as Minitab for data analysis.
  • Oversee product testing to ensure compliance with applicable requirements.
  • Apply Design Control principles to support sustaining engineering and product updates.
  • Resolve quality issues and support design changes with cross-functional teams.
  • Apply risk management techniques to identify and mitigate product risks.
  • Use structured problem-solving methodologies to address product and process challenges.
  • Prepare technical documentation reports and presentations for stakeholders.

Required Qualifications

  • Experience with quality engineering in manufacturing or medical device environments.
  • Strong knowledge of design control risk management and process validation.
  • Hands-on experience with DFMEA PFMEA V&V activities and statistical tools (Minitab).
  • Ability to support sustaining engineering and design updates.
  • Strong analytical communication and problem-solving skills.
  • Experience collaborating with engineering manufacturing and quality teams.
Sr. Design Quality Engineering Location: Irvine California Job Type: C2C Hybrid Pay Rate: $50/hr Industry: Manufacturing / Medical Devices End Date: 01-Jan-2026 Job Description We are seeking a Sr. Design Quality Engineering professional experienced in ensuring product quality compliance supporting...
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