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Orbit Bearings
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Jr. Engineer (QMS)

Jr. Engineer (QMS)

Orbit Bearings

0 - 2 years

3 - 4 Lacs

rajkot

Posted:None| Platform:

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Skills Required

internal process audit control plan iso implementation iso audit iso documentation fmea spc system implementation 7qc qms implementation capa customer audits audit documentation qms process audit quality systems quality documentation system audit

Work Mode

Work from Office

Job Type

Full Time

Job Description

QMS Standards Knowledge

Proficient in ISO 9001, with working knowledge of industry-specific standards such as:

ISO 13485 (Medical Devices)
IATF 16949 (Automotive)
AS9100 (Aerospace)

Familiar with global auditing standards and best practices

Auditing

Conduct internal and external audits, including:

ISO audits
Supplier and process audits

Develop and maintain audit schedules, reports, and corrective action plans
Support third-party and certification audits

Document Control

Manage controlled documents: SOPs, Work Instructions, Quality Manuals, and Forms
Maintain document lifecycle through proper version control
Ensure compliance with documentation standards and regulatory requirements

Corrective and Preventive Actions (CAPA)

Perform root cause analysis using methods such as:

5 Whys
Ishikawa (Fishbone) Diagrams

Initiate, implement, and monitor corrective and preventive actions
Track CAPA effectiveness and closure timelines

Risk Management

Conduct Failure Mode and Effects Analysis (FMEA)
Perform risk assessments for products, processes, and system changes
Support risk mitigation planning and continuous monitoring

Statistical Analysis & Quality Tools

Apply Statistical Process Control (SPC) and Measurement System Analysis (MSA)
Utilize quality tools such as:

Control Charts
Pareto Analysis
Histograms
Scatter Diagrams and Process Capability

Process Improvement Methodologies

Apply continuous improvement strategies using:

Lean Manufacturing
Six Sigma (DMAIC methodology)
Kaizen principles

Conduct value stream mapping and implement waste reduction initiatives

Regulatory Compliance

Ensure compliance with relevant regulatory frameworks, including:

FDA (21 CFR Part 820)
CE Marking requirements
Good Manufacturing Practices (GMP)
Other region/industry-specific regulatory bodies

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