Engineer Staff, Quality

2 weeks ago

Aliso Viejo, United States MicroVention Full time
Job Description

Production Support Focus
Lead quality engineering projects to support the manufacturing of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Support manufacturing process changes and product design improvements.

Product Development Focus
Lead quality engineering projects to support the development of medical devices. Work with Manufacturing and R&D in leading efforts to resolve product quality issues. Work with R&D and Manufacturing to lead design control activities for the implementation of new products and product design improvements.

Job Duties Production Support
  • Provide technical skill in many areas of quality engineering such as nonconformances, evaluating inspection data, evaluating process changes, implementing risk analysis, performing test method validations, and analyzing data.
  • Supervise technical activities of Technicians and Engineers involved in quality engineering.
  • Lead efforts to resolve product quality issues.
  • Review component and assembly nonconformance's and provide direction in material review board.
  • Work with Manufacturing Engineers to review process changes.
  • Work with suppliers to maintain high quality levels of incoming production materials.
  • Conduct quality audits of suppliers.
  • Coordinate and assist with first article inspections.
  • Conduct or review test method validations.
  • Coordinate implementation of new equipment by reviewing equipment specifications and related qualifications.
  • Prepare or review risk analysis documents including product risk assessments and FMEAs.
  • Lead activities in various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
  • Largely self-directed and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.
  • Some travel required (approximately 10%).
  • Perform other duties and responsibilities as assigned.
Job Duties Product Development
  • Provide technical skill in many areas of quality assurance such as design control, risk analysis, design verification, design validation, process validation, test method validation, statistical sampling, and data analysis.
  • Supervise technical activities of Technicians and Engineers involved in quality engineering.
  • Work with R&D on design verification and design validation testing of new products.
  • Work with R&D and Quality Engineers on preparing quality specifications and receiving specifications.
  • Coordinate and assist with first article inspections.
  • Help define biocompatibility testing and evaluate test results.
  • Conduct or review test method validations.
  • Coordinate implementation of new equipment by reviewing equipment specifications and related qualifications.
  • Prepare or review risk analysis documents including product risk assessments and FMEAs.
  • Support various Quality Systems such as CAPA, Non-Conformance (NCR), supplier quality, equipment calibration, internal auditing, and quality metrics data analysis.
  • Conduct quality audits of suppliers.
  • Participate in developing improvements to quality system procedures.
  • Analyze products returned from customers.
  • Largely self-directed and proactively motivated. Capable of meeting goals with minimal supervision and managing multiple concurrent projects.
  • Some travel required (approximately 10%).
  • Perform other duties and responsibilities as assigned.


Qualifications

  1. Bachelor's degree in Engineering or related field.
  2. Minimum of six (6) years of experience in Manufacturing, Quality Engineering/Quality Control and Operations, R&D, design control, risk analysis, design verification, design validation, process validation, test method validation and data analysis.
  3. Demonstrated command and knowledge of FDA and ISO medical device quality system requirements.
  4. Proven experience in statistical analysis (statistical analysis tools).
  5. Proficient computer skills including MS Word, Excel, and statistical software (e.g., MiniTab, Statgraphics, Design of Experiment DOE, etc.).
  6. Solid written and verbal communication skills.
Desired Qualifications
  1. Ability to provide technical leadership in process validation, test method validation, data analysis, design control, risk analysis, design verification, and design validation.
  2. Strong knowledge of medical device design control process.
  3. Ability to understand the technology related to MicroVention's products.
  4. Strong knowledge of medical product quality assurance.
  5. Strong mathematics skills with working knowledge of statistical tools.

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