Design Quality Engineer

4 months ago

Irvine, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Interfaces with R&D, Regulatory Affairs, Clinical, Marketing, Process Development and Manufacturing functions in a project team environment
  • Continually seeks to drive improvements in product and process quality.
  • Implement, maintain and update procedures that ensure that R&D documentation constantly meets the Product Development Process and Design Control requirements.
  • Participates in Risk Management activities throughout product lifecycle
  • Perform quality activities (risk management, FMEA, creation of documents, document review) according to project schedule
  • Use statistical and risk management techniques for design and manufacturing and medical device industries
  • Provides the quality/independent review at defined design reviews, project design plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
  • Identifies and resolves complex exceptions to work assignments.
  • Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings.
  • Build Quality into all aspects of work by maintaining compliance to all quality requirements.
  • Keeps up to date on all ISO/EN/FDA/MDD/ MDR and other Product Development related regulatory requirements and relay this information to the Product Development group.
  • Co-ordination of team activities in line with departmental objectives and project goals
  • Supervision and development of staff reporting to them in line with departmental and project goals.
  • Coaches' others in analysis and decision making.
  • Provide guidance on design control requirements to PDP/TDP teams and sustaining engineering activities in line with BSC policies and procedures.
  • Can Lead and Manage Team at onsite/offshore
  • GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
  • Strong creative, analytical and problem-solving skills.
  • Proficient at interpreting data and putting that data into a report
  • Proficient at statistical analysis
  • Experience in EU MDR or other regulatory related projects
  • Verification and Validation
  • CAD Support (Preferred Auto CAD and Solidworks)
  • Experience in creating PFMEAs & Writing reports
  • Process experience, ability to observe and understand manufacturing processes
  • Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
  • Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
  • Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)
  • 5+ Years

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