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Responsibilities:

• provide quality engineering support and direction in quality assurance, control, and preventative activities. You will focus on continuous improvement of products and processes, advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers.
• You will work closely with operations and the business functions to ensure quality performance of product and processes.
• You will work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
• You will have oversight of NC/CAPA execution and act as a mentor in problem-solving and root-causing activities.
• You will lead and participate in the development and improvement of the PFMEA & inspection processes for existing products.
• You will review and execution of change management activities.
• You will maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, take action as necessary.
• You will support execution and analysis of complaints and product field actions.
• You advocate of Human Factor practices, familiarity in the science of Human Factor identification, reduction, and mitigation.
• You proficient understanding of risk management practices and concepts.
• You will participate and interface in internal audits providing effective narrative and description of topic of expertise, participate in external audit preparation building confidence and proficiency in interactions.
• You will assist in the development and review of process and equipment validation/qualification. Build proficiency in validation processes.
• You will support manufacturing transfers, supplier changes, and PPAP to minimize quality issues.
• You will be responsible for initiation, internal containment, and support of commercial holds for potential product escapes.

Requirements:

• Bachelor's in electrical engineering or related discipline required
• Minimum of 2+ years of experience in a regulated industry, ideally with an electrical focus
• MS, CQE, or CRE preferred, Six Sigma Green or Black belt preferred.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desired.
• Understanding of US and International Medical Device Regulations highly desired
• Familiarity with ISO 13485, GDP, GMP desired.
• Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics) desired.