Quality Engineer

Job Description

• Role and Responsibilities
• Assist in the investigation and corrective actions of quality issues related to customer complaints, corrective action requests and Non-Conforming product reports.
• Collect, analyze and present quality data. establish and optimize quality inspection methods, develop and evaluate test methods and product specifications.
• Lead and document design review and risk assessment activities (FMEA) and ensure validations are conducted to the depth commensurate with identified risk.
• Employ statistical sampling plans, analyze adequacy of inspection criteria and techniques, recognize critical attributes when establishing validation requirements.
• Develop and write protocols for new procedures. Review and edit existing procedures.
• Work with Product Development/Engineering to implement new products to market.
• Responsible for participating in design and development projects and assuring the design process meets all requirements.
• Maintains applicable portions of the design history file for assigned projects, adhering to Arthrex design control procedures.
• Supports other engineering activities, including analysis, test execution, evaluation, and other functions.
• Responsible for writing and/or assisting in the writing of validations, work instructions, and test reports.
• Initiates CAPA and QMS related documentation
• Assists in the creation, investigation, and disposition of nonconforming product.
• Supports production related processes and issues, including rework, troubleshooting, quality inputs, and resolutions.
• Works with suppliers to improve quality and assists with product related issues.
• Assists in complaint investigations related to product quality, including review of DHR’s and other supporting roles.
• Assists in training QC Inspectors on inspection techniques and the use of new equipment, including developing methods and tooling for test and inspection.
• Participates in Internal and External quality audits as needed.
• Qualifications and Education Requirements
• Bachelor's degree in engineering or science related field and minimum 3 years of quality engineering experience within Medical Device Industry
• CQE desirable but not required
• Internal/External auditing experience (CQA desirable but not required)
• Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485)
• Ability to understand various manufacturing processes
• Strong working knowledge of applied statistics and quality engineering techniques including Measurement Systems Analysis (Gage R&R), descriptive statistics, Design of Experiments (DOE), Process Capability (Cpk/Ppk), Failure Mode and Effects Analysis (FMEA), Control Plans, Statistical Process Control (SPC)
• Experience in validation/qualification techniques including IQ, OQ, PQ
• Excellent writing and communication skills
• Ability to interface well with others working at all levels
• Ability to develop and implement procedures
• Knowledge of statistical based computer programs such as Minitab, or Statistica, as well as Microsoft Office.
• Ability to read and understand CAD drawings
• Experience in a Class II Medical Device company, and 510K submissions