Senior Quality Engineer
Gentuity is an exciting and highly innovative medical technology firm, active in the research and development, clinical translation, and commercialization of vascular imaging devices. This opportunity provides the candidates the unique chance to work on innovative medical products, with the potential to significantly change the practice of medicine in the care of patients suffering from a wide range of highly debilitating vascular diseases.
This role will be supporting sustaining manufacturing activities for existing medical device products, supplier management activities, customer satisfaction and design/process improvement for existing medical devices. In addition, will be a key team member on design transfer activities for new products. Lastly, this role will be critical for maintaining the risk management files across all the Gentuity product lines.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
• Supports regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
• Key opinion leader for the oversight over manufacturing of assigned products, assuring compliance with DMR and quality system requirements and assuring complete and correct Device History Records are maintained.
• Lead product and process improvement initiatives.
• Leads and maintains the development, completion, and maintenance of risk analyses.
• Supports the generation and completion of protocols and reports for product, process, and test method validations.
• Support the development implementation, and maintenance of defect categories.
• Collaborates with Manufacturing Engineers to review processes for new and existing products and supports the coordinate of process validations and capability studies.
• Lead the development of various inspection techniques and procedures to ensure product integrity to design specifications.
• Lead the disposition of non-conforming materials meet all necessary regulatory requirements, support the investigation process and assure adequacy of corrective actions to prevent re-occurrence.
• Conducts complaint investigations and remediation recommendations as needed.
• Lead CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
• Conduct Supplier Audits and investigations as needed.
• Provide leadership and oversight for Supplier Qualifications process.
• Leads the product transfers process and the construction of any Device History Files.
• Experience with Microsoft programs and statistical programs (i.e. Minitab)
• Proficiency in statistical tools (i.e. Gage R&R, Capability Analysis, Anova, etc.)
• Proficiency in the use of root cause analysis tools (i.e. FMEA, Fishbone Diagram, 5 Why, 8D, etc.)
• Experience with intravascular catheters and/or electro-mechanical hardware a plus.
• Medical device software experience a plus.
• Experience with sterile product preferred.
• Solid Understand of medical device ISO 13485, FDA 21 CFR 820
• Familiar with MDR (EC) 2017/745/MDD, ISO 14971
• Ability to read and interpret drawings
• Experience and demonstrated proficiency in Process Validation (IQ, OQ, PQ, TMV)
• Proficiency in the usage of Six Sigma Methodologies and Lean concepts
• Knowledge and experience in Risk Management (ISO 14975)
• Detail oriented with strong organization skills
• Ability to work cross functionally and as part of a project team
• Self-Motivated and strong ability to adapt to change
• Experience with conflict management
• Bachelor + minimum of 4 years of relevant experience
• Six Sigma Green Belt
• Internal Auditor Certified
• Certified Quality Engineer preferred