Senior Quality Engineer - Medical Devices

Posted 10 January 2024
Salary Negotiable
Job type Full Time
Discipline Medical Devices
Contact NameChristopher Gomez

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 +44 (0)20 3854 7700.