Our client is seeking a Quality Engineer for their team who will be responsible for developing, implementing the internal manufacturing quality processes and procedures, along with continuous improvement and review of assemblies and also customer support for quality initiatives.
Required:
- Bachelors Degree
- Medical Device product experience
- contract manufacturing industry experience
- 4 years experience
- PCBA and mechanical assemblies
- ISO regulated experience
location: Milpitas, California
job type: Permanent
salary: $90,000 - 100,000 per year
work hours: 8am to 4pm
education: Bachelors
responsibilities:
- Certified IPC610, J-STD 001, and 7721/11 trainer, capable of training both exempt and non-exempt personnel
- Lead auditor for ISO 9001, 14001, 13485, and OHSAS 18001 standards
- Mentors inspectors, assemblers, and manufacturing personnel to develop expertise
- Verifies compliance of finished assemblies with drawings based on customer and industry standards
- Creates and coordinates First Article Inspection (FAI) reports and decides on manufacturing line release
- Sets quality plans and goals for PCB Assembly and Box build process control for new products
- Conducts statistical analysis using trend charts, control charts, Pareto charts, DOE, PFMEA, etc.; reviews and verifies Quality reports
- Performs reject verification and analysis, providing feedback for process/product improvements
- Acts as the technical contact for product quality between the company and customers
- Develops product-specific quality inspection plans
- Utilizes quality tools for planning and improvement
- Makes production stop decisions at any stage if needed
- Coordinates customer audits and approvals for product deviations
- Arranges product audits as necessary
- Reads and interprets detailed assembly-level drawings and customer specifications
- Conducts complex and simple inspections using tools like CMM, micrometers, calipers, and other precision instruments
- Manages root cause analysis requests and coordinates customer 8D reports with engineering
- Uses precision measuring devices and electronic equipment to ensure product compliance
- Leads Quality CIP (Continual Improvement Process) team efforts
- Provides training on quality standards, procedures, and instructions as required
- Coordinates and manages internal rework processes
- Works independently with minimal supervision, maintaining strict quality standards
- Supports and improves production processes as needed
- Interfaces with and supports internal teams, such as production, quality, and engineering; sets up meetings as required
- Adheres to all health and safety policies consistently
- Supports the Quality Management System, ensuring ISO-based registrations and controls align with facility business plans
- Performs related and miscellaneous duties within the general occupational series and responsibility level
- Executes tasks according to engineering instructions, company SOPs, professional training, customer requirements, and personal experience
qualifications:
- Experience level: Experienced
- Minimum 5 years of experience
- Education: Bachelors (required)
skills:
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
Qualified applicants in San Francisco with criminal histories will be considered for employment in accordance with the San Francisco Fair Chance Ordinance.
Qualified applicants in the unincorporated areas of Los Angeles County with criminal histories will be considered for employment in accordance with the Los Angeles County's Fair Chance Ordinance for Employers.
We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
