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.

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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

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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.