Job Details

ID #45928020
State California
City Fremont
Job type Permanent
Salary USD US110000 - US120000 per annum US110000 - US120000 per annum
Source Ledgent Technology
Showed 2022-09-23
Date 2022-09-22
Deadline 2022-11-20
Category Et cetera
Create resume

Quality Engineer

California, Fremont, 94538 Fremont USA

Vacancy expired!

We are looking for a Quality Engineer with the below background.

SUMMARY

The Quality Engineer is responsible for providing experienced quality assurance to support production, internal and external customers, interacting with other departments, suppliers, and customers on technical and quality matters for process improvement. Responsible for maintenance, improvement, and compliance with the Quality Management System (QMS) to meet customer requirements, regulatory and compliance requirements, quality standards, company goals, and objectives.

Responsibilities:
  • Support production and quality team in quality and process control for prototype, NPI, and sustaining products through quality control plan of the front end (PCBA) and back end (Box Build). Created the quality checklist for inspection.
  • Use quality tools to analyze quality data and conduct a periodic quality meeting with the internal team and customer for process improvement.
  • Lead cross-functional problem-solving team and implement quality tools & techniques to overcome barriers to continuous quality improvements.
  • Continually looks for improvement and makes appropriate recommendations.
  • Manage DMR, MRB, RMA, and CAPA processes to ensure they are compliant with company procedures.
  • Oversee the Corrective Action/Preventative Action (CAPA) process. Initiate CAR/8D to the internal team or supplier and follow up until it is closed.
  • Review customer data for quality clauses and conformity and respond to customer quality feedback.
  • Support incoming inspection and provide guidance for MSA & AQL.
  • Perform risk assessment for the quality process including FMEA.
  • Work with process engineers and other teams for product & process validation (IQ, OQ, PQ).
  • Support equipment calibration and maintenance to it is compliant with customer requirements, FDA regulations, and ISO specifications.
  • Ensure the production floor is compliant with company ESD procedure or ANSI/ESD 20.20 standard.
  • Create and maintain QMS documentation to meet the company, regulatory and compliance requirements.
  • Schedule, plan and perform annual internal audits for ISO 9001, ISO 13485, FDA, and AS 9100. Generate internal audit reports.
  • Issue Quality Alert and participate in the Purge process.
  • Ensure that all production critical supplier issues are resolved in a timely manner, and corrective actions are implemented correctly.
  • Monitor and drive PPM issues with the supply base in addition to helping them achieve "Dock to Stock' in accordance with the vendor performance system. Audit supplier as needed.
  • Support all corporate and site 6S objectives.
  • Perform all other duties, as assigned.
  • Establish a collaborative working relationship with all departments. Maintain company quality and ethical standards.

Job Knowledge, Skills & Abilities:
  • Knowledge of ISO 9001, ISO13485, FDA-Registration, 21CFR820, and AS 9100
  • Excellent organizational skills and attention to detail.
  • Extensive knowledge of or the ability to quickly learn production processes.
  • Deep understanding of the PCBA process.
  • Experience in dealing directly with customers regarding quality issues.
  • Experience in a PCBA low volume high mix or PCBA NPI desired.
  • Knowledge of IPC-DVD-64C Component Identification.
  • Certified as IPC-A-610 CIS or CIT preferred.
  • Understanding of IPC-A-620 and J-STD-001 requirements.
  • Ability to interpret all customer documents and related specifications.
  • Proficient with Microsoft Office Suite or related software.
  • AS/AA degree. Bachelor's Degree preferred.
  • 3+ years of related experience required in a quality organization working preferably within a manufacturing environment.
  • Knowledge of lean and six sigma methodologies preferred.

We are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.

Vacancy expired!

Subscribe Report job