The Quality Engineer is responsible for overseeing quality functions in Materials Control and on the Production floor. That includes developing and implementing the internal manufacturing quality processes and procedures, continuous improvement, review of assemblies, providing full support to customers, and managing quality initiatives such as inspection plans, MRB, and RMAs.
Essential Functions and Responsibilities:
- Performs statistical analysis of process through the use of trend charts, control charts, pare to charts, DOE, PFMEA, etc.; reviews/ verifies Quality reports and presents reports internally or to customers as needed.
- Coordinates customer audits and special customer approvals for deviations in regards to assigned products
- Correctly reads and interprets detailed, assembly-level drawings and Customer specifications to establish quality plans and sets quality goals for PCB Assembly and Box build process control for new and existing products as needed.
- Assists inspector in creating First Article Inspection (FAI) reports and helps deciding whether to release the manufacturing line. Verifies compliance of finished assemblies with drawing requirements based on customer and industry standards.
- Performs reject verification and analysis to provide feedback to production line engineering for process or product improvement.
- Request and manage product and process root cause analysis with the engineering team; create and coordinate customer 8D reports
- Makes decisions for production stop at each production step if needed
- Mentors inspectors, assemblers, and manufacturing personnel to gain the ability and experience to help them grow. 20Performs training on quality standards, procedures, and work instructions as needed.
- Familiar with and utilizes precision measuring devices (e.g., CMM, micrometers, calipers, parallels, sine bars, height masters, etc.) and electronic equipment to ensure compliance of parts and product with established standards and specifications and when needed conducts simple and complex product inspections using these inspection instrumentation and equipment.
- Leads and drives the effort for the Quality CIP (continual improvement process) team and supports a Quality Management system including conformance to ISO based registrations and controls for the facility.
Requirements:
- Experience with Medical Products
- Possess a Bachelor's degree in a related field or equivalent experience
- Quality training, document control training, quality standards, ISO, six sigma are all preferred training, Kaizen and lean Manufacturing techniques
- Use of quality engineering methods in inspection
Preferred Skills
- Experienced with medical products and GMP manufacturing.
- Certified IPC610, J-STD 001, and 7721/11 trainer with ability to train exempt and non-exempt personnel.
- Lead auditor for ISO 9001, 14001, 13485 and/or OHSAS 18001.
- Sets up product audits as needed
- Assistance with bringing up of at least one (1) ISO standards implementation (i.e. 9001, 14001, 13485, etc.)
- Experience with developing and documenting procedures