Quality Engineer

Job Description:

• Support and Lead Design Assurance engineering activities in support of Software Product
• Development and Software Life Cycle processes including design controls, quality planning, risk assessments/analysis/management, design reviews, test method development and validation, design and process verification and validation test plans and reports, post-market monitoring, investigations, follow-up and reporting

• Insure that Design controls are compliant with IEC 62304.
• Familiarity with TIR45 and Agile methodologies.
• Insure that FDA and other regulatory knowledge and experience is applied to risk and testing assessments
• Investigation and review of customer complaints, ensuring that root cause investigations are thorough and corrective / preventive actions are robust
• Work with manufacturing engineering to ensure necessary process controls are in place for design changes.
• Review and approve Engineering Change Orders (ECO) and support the material review board (MRB) processes as needed
• Act as an effective team member in the execution of Quality functions in compliance with FDA QSRs
• (Design Control, CAPA, etc), ISO 13485, MDD, CMDR, CMDCAS and other national and internationalquality and regulatory requirements and standard
• Contribute to the design, development and implementation of product assurance plans providing feedback to corrective and preventative actions to engineering, manufacturing, service and field operations and supplier performance
• Collect, analyze & report on quality system metrics: CAPA, complaint trends, manufacturing trends, etc.
• Develop statistically sound sampling plans and perform data analysis
• Assess reliability growth strategies in both systems and software and provide input to the engineering