Quality Engineer (SMT/PCBA)

Quality Engineer (SMT/PCBA) 1621 Barber Ln, Milpitas, CA 95035 $90,000

• $98,500 a year
• Full-time $90,000
• $98,500 a year

•

Full-time Job Description/Responsibilities:

Support

ISO 9001

2015, AS9001D, ISO 13485:2016 internal audit and implementation. Ensure quality related deliverables are met as defined by the product development process and project plans. Provide Quality Engineering and Assurance Services and Technical Expertise to support product quality and overall system compliance. Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements. Work with Manufacturing and Process Engineering to ensure product quality. Work with Customer SQEs and other related engineering fields in the completion of Product Qualification Process (PQP) and Production Part Approval Process (PPAP). Coordinate and manage the Corrective and Preventive Action system (CAPA). Lead Root Cause Investigations efforts using common Root Cause Analysis Methodologies (5 Whys, Fishbone Ishikawa, Pareto Charts, etc.) Active involvement in maintaining, reviewing, and reporting Quality Performance Data (KPIs) and opportunities for improvement for management review. Evaluate product and process changes to assure compliance with regulatory, corporate, customer, and 3rd party safety requirements (UL, Intertek, CCC, Etc.). Participate in MRB/CPI to engage with process and yield improvement Monitor RMA return rate and support FA / Process improvement Ensuring that the quality management system conforms to the requirements of International Standard. Ensuring that the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Job Requirements:

Bachelor's Degree in Technical Discipline (Engineering, Math, Science or Equivalent Experience) At least 5 years of experience in contract manufacturing in PCBA and Box Build Assembly. Extensive knowledge and certified internal auditor in

ISO 9001

2015, ISO13485:2016 and AS9100D Familiar with DOE, FMEA, PPAP, SPC, PQP, TQM, ISO, Six Sigma Knowledge of the basic QA functions i.e. IQA, FQA, MRP, RMA, FAI, QCC, CAPA, SCAR, etc. Strong analytical skill and hands-on problem solver with decision making background. Strong Knowledge in Microsoft Office (Word, Excel, PowerPoint, Access Database) Understand SMT processes and quality requirements Good communication and writing skills Strong knowledge of PCBA (SMT and PTH) Box-Build and repair (RMA) business a must. Must be familiar with medical products requirements. Knowledge in IPC, Bellcore, and JEDEC standards. Statistical Process Control and / or Six-Sigma capabilities. Must be able to work independently with minimum supervision. Preferred Experience in PFMEA and Process Control Plans Experience in Eight Disciplines (8D) Problem Solving Methodology

IPC-A-610 & J-STD-001

CIS or CIT Certification ISO9001, ISO13485 and AS9100

Internal Auditor Certification Pay:

$90,000.00

• $98,500.

00 per year

Benefits:

401(k) Dental insurance Employee assistance program Employee discount Flexible spending account Health insurance Life insurance Paid time off Vision insurance

Work Location:

In person