Quality Engineer (QMS/Auditor)

SoloPoint Solutions, Inc.

Fremont, CA

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JOB DETAILS

SKILLS

8D, American Society for Quality (ASQ), Auditing, Certified Quality Engineer (CQE), Communication Skills, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Document Management, Engineering, Gap Analysis, ISO 9001, Internal Audit, Maintain Compliance, Manufacturing, Manufacturing Management, Minitab, Performance Analysis, Performance Management, Performance Metrics, Problem Solving Skills, Purchasing/Procurement, Quality Engineering, Quality Management, Risk Analysis, Risk Management, Root Cause Analysis, Sales, Six Sigma Black Belt, Six Sigma Green Belt, Standard Operating Procedures (SOP), Statistics Software, Team Lead/Manager, User Documentation

LOCATION

Fremont, CA

POSTED

30+ days ago

Qualifications:

BS in an Engineering, Manufacturing, Quality Management
5+ years in Quality Engineering experience in a industrial manufacturing environment
Demonstrated experience of at least one successful case of leading the complete implementation of ISO 9001 from scratch to certification.
Required - ISO 9001 internal auditor or chief auditor certification
ASQ Certified Quality Engineer (CQE) or Six Sigma Green/Black Belt
Proficient in ISO 9001:2015 standard requirements.
Excellent cross-departmental communication skills can influence stakeholders at different levels.
Data-driven decision-making ability, and proficiency in statistical software (such as Minitab) or SPC tools.
Mandarin speakers prefer not required

Responsibilities:

QMS Planning and ISO 9001 Certification
Gap Analysis: Assess the differences between existing processes and the ISO 9001 standard.
System design: Define the scope of QMS and design core processes (such as sales, production, procurement, after-sales service, etc.).
Documentation management: writing, reviewing and maintaining quality manuals, second-level procedure books, third-level work instructions (SOPs) and forms and records.
Audit Window: Serves as the sole technical contact point with external certification bodies and clients and leads the certification audit process.
Company-wide training: Conduct ISO 9001 concept training for colleagues across departments to ensure that everyone understands their role and responsibilities in the QMS.
Internal Audit: Develop an annual audit plan, train internal auditors, and conduct internal audits to ensure compliance.
Management Review: Assist senior management in conducting management review meetings and reporting on quality performance and improvement needs
Performance monitoring: Establish and track key quality indicators (KPIs), such as defect rate, customer complaint rate, and corrective and preventive action (CAPA) achievement rate.
Problem Solving: Lead the team to use tools such as 8D, 5 Whys, or Fishbone to conduct root cause analysis and track the effectiveness of improvements.
Risk management: Apply risk identification and risk assessment methods to prevent potential quality failures.

Quality Engineer (QMS/Auditor)

SoloPoint Solutions, Inc.

Fremont, CA

About the Company

SoloPoint Solutions, Inc.

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