Coordinate quality engineering activities to achieve business objectives.
Provide guidance and leadership on development /review of validation policies, master plans and protocols and quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.
Support site production and engineering functions in process quality improvement activities.
Manage the internal and supplier audit processes. This includes, but is not limited to, preparation of audit schedule and audit assignments, training auditors, conducting audits, and monitoring the performance of the audit process, as appropriate. Perform internal and/or supplier audits as required.
Manage the risk documentation process, ensuring that product FMEAs, Hazard assessments, etc. are regularly updated as required.
Provide guidance and leadership on investigations involving manufacturing nonconformance’s, product or component failures, customer complaints, or product returns by leading or participating in the investigation process, technical troubleshooting, FMEA, hazard, or other risk analysis, determining root cause and recommending CAPA.
Interface with external auditors (Notified Body, FDA, etc.) during audits at the Monrovia site; participate in the preparation and completion of corrective action plans as needed.
Provide guidance and leadership on statistical methodologies, risk analyses and other quality engineering tools.
Compile Quality metrics, analyze trends and report to Quality Management.
Provide guidance and leadership on design process characterization studies (DOE, R&R); conduct statistical analysis of results to identify critical parameters and improves process capability.
Perform additional duties as assigned.
EDUCATION & TRAINING
BS in Engineering or sciences with minimum experience below.
EXPERIENCE
1-2 years experience in risk management, FMEA, CAPA, and validation experience preferred.
Experience in vision care or intraocular lens industry preferred.
General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required.
Applicant must be knowledgeable about regulatory/compliance/validation issues, be self-motivated, intelligent and reliable.
SKILLS
Excellent project management, organization, writing, communication and presentation skills required.
Ability to communicate in a wide variety of communication styles and to influence and build consensus across cross-functional groups.
Must have strong written and oral communication skills.
Experience in writing technical documents, especially compliance and/or Validation/quality assurance documents and protocols will be required.
Ability to format, trend and present information using basic quality tools (i.e., scatter plots, histograms, pareto diagrams, flow charts, SPC, FMEA, Fault Tree Analysis, etc.).
Ability to compile, analyze, graph, and compare data using standard statistical techniques (i.e., t-tests, ANOVA, linear regression analysis, etc.).
Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.
Proficiency in written and spoken English required.
