Quality Engineer Medical Devices in Milpitas

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Ultimate Staffing is seeking a Quality Engineer with Medical Devices background for our client in Milpitas. This is a 100% onsite, Direct Hire role with a starting salary of $90K - $120K. Candidates must come from the Medical Device Industry.

Position Summary:

The Quality Engineer reports directly to the Quality Manager and is responsible for developing, implementing the internal manufacturing quality processes and procedures. This includes continuous improvement and review of assemblies and also customer support for quality initiatives. The Quality Engineer may perform a variety of tasks in accordance with their training, experience, and skill.

Essential Functions and Responsibilities:

· Certified IPC
610, J-STD 001, and 7721/11 trainer with ability to train exempt and non-exempt personnel

· Lead auditor for ISO 9001, 14001, 13485 and OHSAS 18001

· Mentors inspectors, assemblers, and manufacturing personnel to gain the ability and experience to help them grow into higher levels of expertise

· Verify compliance of finished assemblies with drawing requirements based on customer and industry standards.

· Creates and coordinates First Article Inspection (FAI) reports and decides whether to release the manufacturing line

· Evaluates and establishes quality plan and sets quality goals for PCB Assembly and Box build process control for new products as needed

· Performs statistical analysis of process through the use of trend charts, control charts, pareto charts, DOE, PFMEA, etc.; reviews and verifies Quality reports

· Performs reject verification and analysis to provide feedback to production line engineering for process or product improvement

· Is the technical contact person between Zollner and customers in regards to product quality

· Creates product-specific quality inspection plans

· Uses quality tools for quality planning and improvement

· Makes decisions for production stop at each production step if needed

· Coordinates customer audits and special customer approvals for deviations in regards to assigned products

· Sets up product audits as needed

· Correctly read and interpret detailed, assembly-level drawings and Customer specifications.

· Conduct simple and complex product inspections using a variety of inspection instrumentation and equipment (e.g., CMM, micrometers, calipers, parallels, sine bars, height masters, etc.)

· Request and manage product and process root cause analysis with the engineering team; create and coordinate customer 8D reports

· Familiar with and utilize precision measuring devices and electronic equipment to ensure compliance of parts and product with established standards and specifications.

· Leads and drives the effort for the Quality CIP (continual improvement process) team

· Performs training on quality standards, procedures, and work instructions as needed

· Coordinates and manages internal rework

· Performs with minimum supervision and technical assistance; while maintaining strict adherence to quality standards.

· Support and improve production processes as needed.

· Interface and support internal customers (production, quality, engineering, etc.) and sets up meetings as needed

· Follows all health and safety policies at all times.

· Supporting a Quality Management system including conformance to ISO based registrations and controls for the facility business plan based upon targeted market sectors.

· Performing related duties and miscellaneous tasks as assigned (Related duties as assigned are duties that may not be specifically listed in the class specification or position description, but are within the general occupational series and responsibility level typically associated with the employee's class of work.)

· Tasks may be performed in…