Manufacturing Quality Engineer

International Association of Plumbing and Mechanical Officials (IAPMO); Milpitas (CA); Hybrid; USD 95,000 - 130,000; Full time

Job summary

The International Association of Plumbing and Mechanical Officials (IAPMO) in Milpitas, CA is seeking a Quality Assurance professional to lead internal audits to ISO 9001:2015, ISO 13485:2016 and AS9100D compliance. You will provide QA engineering support, drive CAPA, PQP/PPAP processes, and monitor KPIs to improve product quality and regulatory compliance.

Ideal candidates have 5+ years in contract manufacturing for PCBA and Box Build, strong problem-solving skills, and advanced proficiency in

Qualifications

• Bachelor’s Degree in Engineering, Math, Science or equivalent.
• At least 5 years in contract manufacturing for PCBA and Box Build Assembly.
• Certified internal auditor in ISO 9001:2015, ISO13485:2016 and AS9100D.
• Familiar with DOE, FMEA, PPAP, SPC, PQP, TQM, ISO, Six Sigma.
• Knowledge of QA functions IQA, FQA, MRP, RMA, FAI, QCC, CAPA, SCAR, etc.
• Strong analytical and problem‑solving skills with independent judgment.
• Proficient in Microsoft Office (Word, Excel, PowerPoint, Access).
• Understand SMT processes and quality requirements.
• Experience with PCBA (SMT and PTH) Box-Build and repair (RMA).
• Experience with medical product requirements.
• Knowledge of IPC, Bellcore, and JEDEC standards.
• Statistical Process Control and Six‑Sigma capabilities.
• Ability to work with minimal supervision.

Responsibilities

• Support internal audits for ISO 9001:2015, ISO 13485:2016 and AS9100D.
• Ensure quality deliverables align with product development and project plans.
• Provide QA engineering support to ensure product quality and system compliance.
• Identify and implement process controls for development and manufacturing.
• Coordinate CAPA and lead root cause investigations (5 Whys, Ishikawa, Pareto).
• Manage PQP and PPAP activities with cross‑functional teams.
• Monitor KPIs and drive continuous improvement.
• Evaluate changes for regulatory and safety compliance (UL, Intertek, CCC).
• Participate in MRB/CPI, RMA monitoring, and yield improvements.
• Ensure QMS integrity during changes.

Skills

Audit & Compliance

Root Cause Analysis

Quality Assurance

Data Analysis

MS Office Proficiency

SMT Knowledge

Technical Communication

Independent Work

Education

Bachelor’s Degree in Technical Discipline

Tools

Access Database

MRP Software

Job description

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

** This role is not eligible for relocation or remote work **