Staff Quality Engineer
Orange County Metro Area, CA
Life Science Industry
Responsible for the development, application, revision, and maintenance of documentation for design control and processing materials into partially finished or finished products, inspection and process development, qualification of equipment, validation of processes, including test method and some level of software validations
- Provides quality assurance support to the company
- Manage or assume functional responsibility for bigger projects or multiple smaller projects
- May supervise other Engineers, or manage other resources (external partners, contracts, budgets, etc)
- May have some type of Financial Responsibilities: cost center and capital purchases
- Demonstrate project ownership and accountability for project results
- Develop working relationships outside of department, cross functionally
- Think strategically as it pertains to a given project
- Demonstrated effective negotiation skills and can work through obstacles effectively
- Essential Team member on design and development projects.
- Lead and direct the project team applying quality tools and methods that improve efficiencies and effectiveness for design and process development
- Lead and/or participate in project teams coordinating efforts of engineers, technicians and other professionals of various disciplines/departments to strategize, design, develop, and execute new product design activities
- Develop technical solutions to complex problems, which require the regular use of creativity
- Perform engineering work typically including one of the following:
- Leader for risk management activities including planning, assessment, quantification, implementation of risk control measures, and effectiveness.
- Participate or lead Usability Engineering activities (depending on proven skills)
- Develop or assist in design verification activities (protocols and reports)
- Develop and execute design validation activities (protocols and reports)
- Develop and execute process validation protocols and reports for manufacturing, inspection, or test equipment
- Develop and validate measurement method; software validation capability a plus.
- Respond to internal CAPA and QA audit findings support developmental projects in the area of validation
- Perform responsibilities required by the Quality System and other duties as assigned or requested.
- General office environment, Labs, Clean rooms
- ASQ Certified Quality Engineer or Six Sigma Black Belt preferred
- Knowledge of quality assurance practices within the medical device industry, including FDA Quality System Requirements (QSR) and ISO 13485
- DMAIC problem solving and analytical skills
- Effective verbal and written communication skills required
- Strong knowledge of statistics and experience with application in a medical device development and manufacturing environment required
- The Staff Engineer requires a minimum of five years of experience
- BS + minimum of 5 years exp. OR MS/MBA + minimum of 4 years exp.
- Up to 25% travel may be required