Validation Quality Engineer Ii (Medical Device)

JOB OVERVIEW

1. Coordinate quality engineering activities to achieve business objectives.

2. Initiate and lead the development /review of validation policies, master plans and schedules, and protocols and quality engineering issues.

3. Support site production and engineering functions in process quality improvement activities.

4. Support 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.

5. Support the risk documentation process, ensuring that product FMEAs, Hazard assessments, etc. are regularly updated as required.

6. Initiate and lead investigations involving manufacturing nonconformances, 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/SCRs.

7. Interface with external auditors (Notified Body, FDA, etc.) during audits at STAAR sites; participate in the preparation and completion of corrective action plans as needed.

8. Apply statistical methodologies, risk analyses and other quality engineering tools to manufacturing and design related issues.

9. Coordinate contractor qualification activities with appropriate departments.

10. Compile Quality metrics, analyze trends and report to Quality Management.

11. Initiate and lead design process characterization studies (DOE, R&R); conduct statistical analysis of results to identify critical parameters and improves process capability.

12. Participate in Design Control on New Product development teams; advise the team on design control requirements; develop, review and approve design control deliverables related to quality engineering and validations.

13. Perform additional duties as assigned by Management.

EDUCATION & TRAINING

• Bachelor’s degree, preferably in Engineering or sciences or equivalent combination of education/experience.

• Advanced degree preferred.

EXPERIENCE

• Three years’ experience in validation and/or quality engineering in the medical device or pharmaceutical industries, including the practical application of FDA Quality System Regulation and ISO 13485 with BA/BS; or minimum two years’ experience with advanced degree.

• 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).

• Ability to compile, analyze, graph, and compare data using standard statistical techniques (i.e., t-tests, ANOVA, linear regression analysis).

• Demonstrated expert knowledge of Windows-based software, including Word, Excel, Access, Project, and Power Point.

• Proficiency in written and spoken English required.

STAAR Surgical is an equal employment opportunity employer.