Position Overview  

The  Sr. Quality Engineer reports to the Quality Engineering Manager and is responsible for developing, implementing, maintaining, and supporting various quality engineering/improvement activities in a fast-paced and dynamic environment.  

Essential Job Functions

Investigate causes of quality problems identified from field complaints, field service records, manufacturing, final QC inspection, incoming inspection, and suppliers. Manage the root cause analysis and corrective actions process of supplier quality issues. Support departmental effort in CAPA investigation and completion. Collect, analyze, trend, and communicate quality data throughout the organization. Identify validation and/or verification required for design changes. Support manufacturing, new product development, and regulatory to ensure compliance with all internal and external requirements; represent quality interests and concerns on project teams. Implement and qualify software tools related to product or process changes. Identify product quality and quality system improvement opportunities and drive procedure updates when required. Carry out supplier qualification or surveillance audits, with supplier support and supplier advanced product quality planning. Write associated audit reports for distribution to senior management. Support new product launches and/or manufacturing transfers and/or sourcing projects to ensure suppliers can deliver to the required quality standards.

Requirements/Qualifications

Bachelor’s degree in Electrical or Mechanical Engineering (or similar) required. Minimum of 4+ years of hands on experience with quality engineering manufacturing and field support. Prior experiences in a regulated environment, preferably medical device. Familiarity with use of mechanical and electrical test equipment. Basic statistical analysis skills and proficiency with MS Office. Ability to work effectively in a fast paced and dynamic environment. Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers. Strong written and verbal communication skills.