About the Role
The Quality Engineer is responsible for quality planning and continuous improvement, working closely with production/operations and suppliers to reduce defects, improve product quality, and validate processes.
Key Activities
Develop, amend, and implement standard GMPs & SOPs.
Develop and improve production processes.
Identify, prioritize, and drive manufacturing and quality improvement projects.
Manage Material Review Board (MRB) for non-conforming products, working with Manufacturing, Regulatory, and Purchasing Departments for timely disposition.
Draft, review and execute equipment/process validations through IQ, OQ, PQ protocols.
Manage day-to-day quality concerns across process, products, and service of manufacturing suppliers.
Understand quality control in supplier manufacturing operations.
Assess and monitor supplier performance to ensure compliance with company standards.
Review quality planning & control documents including: CAPA, FMEA, Risk Analysis.
Help ensure quality and completeness of design history files, risk management, validation, and change orders.
Conduct complaint investigations, NCR investigations, and CAPA procedures.
Conduct tests and analysis to determine reasons for failures of procured materials, parts and/or processes using various testing methodologies and tools.
Preferred Skills
Thorough understanding of QMSR and ISO 13485:2016 requirements.
Experience in measurement analysis (gage R&R)
Experience with 3D CAD software (SolidWorks preferred)
Experience in statistical analysis
Experience in non-conforming product evaluation/disposition.
Education and Experience
Must Have Medical Device Experience.
BS in Engineering (Mechanical, Industrial, or Biomedical) preferred.
Minimum of 3 years’ relevant experience in the medical device field.
Proven experience sustaining, improving and validating manufacturing processes and equipment associated with medical devices.
About Us
Finding a great opportunity that fosters growth, a great culture, and leadership opportunities can be difficult. Top Quality Recruitment (TQR) connects professionals with leadership opportunities across the Packaging, Food and Beverage, Medical Devices, and Biotechnology industries. With 50+ years of experience, we believe in one-to-one communication and finding the best candidate/employer match possible.
TQR is an equal-opportunity employer that encourages diversity. We will consider all applications.
Accommodation for applicants with disabilities is available upon request.
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