Quality Manager | 40HRS

Quality Manager

Work Location: fremont, California

Job type: Full-Time

Posted: 02-28-2022

Salary: Negotiate

Email: job@40hrs.us

Job Description

Responsible for the maintenance and execution of product quality enhancement or compliance programs in manufacturing, especially on any special or unique requirement stipulated by regulatory agencies or by customers, in the following areas that is,
  1. Supplier Quality Engineering & IQC, 
  2. Quality Assurance(IPQC & OQC) for PCBA and Instrument level manufacturing,
  3. Customer Quality Engineering for the various Business Units,
  4. Quality Management System and Environmental Management System
Main Responsibilities - 
  • Serve as a representative of the Internal QMS Audit Team.
  • Independently lead/participate in compliance audits and identify compliance gaps or risks
  • Provide special/unique poducts and components knowledge 
  • Work with customers/suppliers to ensure that the site set the critical and unique quality standards in compliance with FDA/regulatory requirement for the manufacturing services.
  • Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
  • Provide audit compliance expertise to internal and external customers.
  • Train QA Staff on quality related SOP/WI and ISO9001/13485, cGMP or US FDA 21 CFR Part 820 requirements.
  • Lead respective QA teams and work with HOD to meet site KPI targets and customers’ quality requirement.

Other Responsibilities

  • Lead on matters concerning the development, maintenance and monitoring of effectiveness of the Quality System.
  • Initiate actions to prevent the occurrence/ recurrence of product non-conformity and system deficiency.
  • Investigate into any product non-conformance or matters affecting the Quality System.
  • Drive cross functional teams towards meeting: (1) site KPI targets and (2) customers’ quality targets and requirements, for example, as stated in the Quality Agreement and Quality Management Plan.
  • Support NPI to build a robust quality assurance process.
  • Generate quality plans, control plans, procedures, work instruction for overall quality.
  • Coordinate on effective implementation of such plans, procedures or instructions for compliance with regulatory requirement (e.g. 21 CFR Part 820) and conformance to ISO 9001/13485/14001/customer’s requirements in the manufacture of life science or medical devices.
  • Facilitate in the internal FDA Program Committee Meetings and act as a subject matter expert for the GMP Compliance Audit team.  
  • Partner closely with key stakeholders to lead and implement periodic GMP compliance audits for the site.

Job Responsibilities

Please see JD

Job Requirements

  • Bachelor's Degree in Electronics / Electrical / Mechanical/Industrial Engineering, 
  • Six (6) years of hands-on product quality working experience. 
  • Demonstrate independence and good technical problem solving skill while working with cross-functional team. 
  • Expertise in leading or managing ISO14001, ISO9001 & ISO13485.
  • Good knowledge of Quality Systems and cGMP requirements within a regulated environment.
  • Good understanding of US FDA 21 CFR Part 820 and Part 11 regulatory requirements, QSIT/GHTF/IMDRF guidelines
  • Quality Tools (Acceptance sampling plan, SPC,MSA,FMEA,PPAP,APQP or 7 QC tools, etc)
  • Statistical analysis for problem solving.
  • Relevant IPC, MIL, Jedec, ANSI, etc. standards for electronic devices manufacturing


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