Design Quality Engineer - Katalyst Healthcares & Life Sciences
Irvine, CA 92618
About the Job
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
Source : Katalyst Healthcares & Life Sciences