Job description
Mantell Associates is currently partnered with a leading Medical Devices company on an exciting opportunity for a Senior Quality Engineer to join their growing team.
Senior Quality Engineer - 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
Senior Quality Engineer - Requirements:
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
Mantell Associates is a specialist Pharmaceutical and Life Science headhunting organisation. For more information on this opportunity, get in touch with us at +1 (786) 485 1298.