JOB OVERVIEW

1. Coordinate quality engineering activities to achieve business objectives.

2. Provide guidance and leadership on development /review of validation policies, master plans and schedules, and protocols and quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices.

3. Support site engineering functions in process quality and testing improvement activities. Responsible for various analytical activities related to commercial stability program management of products. Review analytical data associated to these stability studies. Generate protocol and reports.

4. Coordinate GMP activities and ensuring batches are tested and released to meet project timelines for commercial needs.

5. Develop timelines, identify critical analytical issues, lead problem solving of technical issues, as well as investigate and resolve any out of specification results

6. Provide technical expertise to the risk documentation process.

7. 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.

8. Participate in the preparation of nonconformance investigations and responses, and completion of corrective action plans as needed.

9. Provide guidance and leadership on statistical methodologies, risk analyses and other quality engineering tools

10. Support supplier qualification activities and SCRs with appropriate departments.

11. Support regulatory filings including NDA, annual reports, and other documents for filings.

12. 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.

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

14. Other duties as assigned.

EDUCATION & TRAINING

• Bachelor’s degree, preferably in Engineering or Sciences (Chemistry or Microbiology).

• Advanced degree preferred.

• Certified Quality Engineer (CQE) or equivalent preferred

EXPERIENCE

• Five 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; or equivalent combination of education/experience.

• Experience in vision care or intraocular lens industry preferred.

• General knowledge of manufacturing processes such as injection molding, assembly, packaging, and sterilization required.

• Knowledge of international/ISO standards on ophthalmology

• 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.