Quality Engineer will be responsible for supporting, receiving, inspection, and equipment management. Primary responsibilities include receiving materials, performing component inspection, equipment calibration/maintenance, and manufacturing quality support. Engineer performs root cause investigation of nonconformances in manufacturing and receiving. This position implements, maintains and enforces the internal quality management system to meet ISO standards and FDA quality system regulations.
- Perform product and component receiving and inspections in accordance with defined policy and procedures. This includes receiving and inspecting components, subassemblies, labeling, and finished products to support production.
- Perform component inspections using tools such as calipers, micrometers, gauges, and tensile testers. Develop test procedures for inspection.
- Maintain, support, and continuously improve the calibration and preventative maintenance program for example, a) coordinate calibration work orders, calibration certificates, and calibration files, b) assisting and supporting coordination of on-site and off-site calibration and repair activities, c) serve as a contact for customers, vendors and equipment service personnel.
- Manage and perform routine calibration and preventative maintenance of equipment and tooling to ensure proper function within specifications. Troubleshoot and diagnose causes of equipment failures and apply corrective actions. Resolve equipment breakdowns in efforts to minimize downtime.
- Perform calibration audits and in-process calibration audits to ensure compliance.
- Support quality system related deliverables including quality system process improvements, non-conformances and CAPAs
- Initiate documentation changes. Maintain accurate documentation and records.
- Define supplier quality specifications, sampling plans, and vendor qualification for purchased components
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Perform other related duties and responsibilities, as assigned.
- Bachelor of Science in engineering, science, or technical field
- 0-2+ years' experience in Engineering and/or Quality.
- Demonstrated ability to effectively and clearly communicate concepts, ideas and knowledge to other individuals and teams.
- Strong analytical and problem-solving skills.
- Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
- Advanced computer skills, including statistical/data analysis and protocol/report writing.
- Strong communication skills, both verbal and written.
- Comfortable working with and seeking optimum solutions with team members in adjacent disciplines of engineering.