Quality Engineer

The Quality Engineer is responsible for supporting all aspects of the organization’s internal and external

Quality standards and initiatives related to compliance, manufacturing, supplier and customer concerns

and requirements, as well as continuous improvement activities.

• Lead and manage the CAPA process to resolve internal and external quality related issues by processing customer complaints/returns and assist in developing and communicating failure analysis and corrective actions.
• Act as the primary liaison with customers on quality related matters, coordinate the flow of information between customers and other departments regarding quality related issues.
• Work within cross functional teams during the NPI process and new customer/product onboarding to assess customer requirements and ensure they are met
• Retrieve and analyze data to identify defect trends and recommend improvements to maintain quality products, systems, and processes.
• Assist in documentation management, training, and review of internal documents and standards.
• Develop and implement quality assurance standards processes and controls by developing and modifying quality procedures and processes to achieve targets associated with KPI Metrics and Quality Objectives.
• Work within supplier management ensuring purchased products meet our needs and expectations through inspection, assessment of supplier, processes, and capabilities and ongoing monitoring of supplier performance.
• Perform internal audits as well as assisting external in auditing requirements (UL, Intertek, etc)
• Responsible for ensuring the monitoring, control, calibration and maintaining measuring and test equipment.

• Familiar with corrective actions, 8D, Fault Tree, Ishikawa, and other related Quality tools
• Detail-oriented with strong documentation discipline
• Ability to work cross-functionally in a highly regulated environment
• Strong communication and interpersonal skills required.
• Strong attention to detail required.
• Proficient in Excel and an ERP system(s).
• Strong knowledge of:

* ISO 13485 (essential) and other ISO related standards

* FDA (QMSR)

* MDR (EU 2017/745) / IVDR (EU 2017/746) as applicable

• Bachelor’s degree in Engineering or related degree or equivalent experience
• 1-2 years Quality related experience required
• Manufacturing experience required, ideally within the electronics industry.