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 - $100K. 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 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 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 accordance with engineering instructions, company standard operating procedures, professional trainings, customer requirements, and individual experience.
Qualifications Required/Job Specifications:
· Must have at least four (4) years experience as a Quality Engineer in a PCBA and Mechanical EMS (Electronic Manufacturing Services) Environment.
· Possess a Bachelor's degree in a related field or equivalent experience.
· Proficient with PC-based software including Microsoft Office Suite, including advanced knowledge of Word, PowerPoint, and Excel.
· Quality training, document control training, quality standards, ISO, six sigma are all preferred training
· Kaizen and lean Manufacturing techniques
· Assistance with bringing up of at least one (1) ISO standards implementation (i.e. 9001, 14001, 13485, etc)
· Experience with developing and documenting procedures
· Use of quality engineering methods in inspection
· Strong, effective organizational skills required; detail oriented; ability to multitask
· Ability to use common sense to solve practical problems.
· Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
· Must have Intermediate to Advanced computer skills with familiarity with MS Office including Word and Excel.
· Strong, effective organizational skills required; detail oriented.
· Manages conflicting priorities in a fast-paced environment, as well as partners with business executives and operations leaders in order to develop appropriate solutions.
· Possess good communication, listening, and interpersonal skills with the ability to relate to individuals from multi-cultural backgrounds, and build trusting relationships in order to gain support and achieve results, at all levels within the organization.
· Must be self-directed, dependable, and motivated with excellent relationship and time management skills.
· Maintaining courteous, professional and effective working relationships with employees at all levels of the organization.
· Develop and maintain courteous and effective working relationships with clients, vendors, and representatives of external organizations.
EMAIL YOUR RESUME
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
