MAIN JOB RESPONSIBILITIES / COMPETENCIES - Coordinate quality engineering activities to achieve business objectives.
- 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
- Prepare and manages equipment qualifications and analytical method transfers/validations in compliance with regulatory/ requirements.
- Support site production and engineering functions in process quality improvement activities.
- Assist with 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.
- Initiate and lead 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 STAAR sites; 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
- Initiate and lead discussions with contractors and vendors. Coordinate contractor qualification activities and SCRs with appropriate departments.
- 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.
- 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.
- Other duties as assigned.
REQUIREMENTSEDUCATION & TRAINING - Bachelor's degree, preferably in Engineering or sciences or equivalent combination of education/experience.
- 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 with BA/BS; or minimum four 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.
- Experience with sample/study management including communication with on-site and off-site packaging representatives to order and obtain stability samples, and with the off-site stability storage facility representatives for placement of the samples
- Experience in packaging, transport, and shelf-life stability studies
- 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.
Pay range: $105K - $125K Final compensation/salary will be depend on experience
STAAR Surgical is an Equal Opportunity/Affirmative Action employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran or disability status, or any other characteristic protected by law.
