Quality Analyst
Quality Analyst
Posted on :
23-06-2025
Employer Active
1 Vacancy
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Job Description
Required Education & Experience
Education: Bachelors degree in Engineering.
Experience: 3 5 years in Quality Engineering preferably in FDA-regulated/Medical Device industries.
Regulatory Knowledge: FDA cGMP ISO ASQC and change control processes.
Preferred Education & Experience
Education: Masters degree in Engineering.
Certifications: Lean Six Sigma (Green/Black Belt).
Required Technical Skills
Execution of IQ/OQ/PQ/MSA protocols for equipment processes and test methods.
Experience with computerized system validations.
Knowledge of FDA cGMP (21 CFR 820) ISO standards and ASQC requirements.
Experience in change control processes and audit readiness.
Proficiency in statistical software (e.g. Minitab) for data analysis.
Ability to perform Root Cause Investigations (RCI) and corrective actions.
Ability to read/interpret blueprints and technical drawings.
Familiarity with CAD or similar engineering tools.
Application of process improvement methodologies (e.g. scrap/defect reduction).
Experience developing/deploying Quality Systems in regulated environments.
Microsoft Office Suite: Advanced skills in Word Excel PowerPoint and Access.
Database Management: Ability to organize and analyze large datasets.
Required Soft Skills
Ability to present complex technical information clearly (written/verbal).
Experience defending validation projects during external audits.
Ability to prioritize tasks manage multiple projects and meet deadlines.
Mentorship of junior engineers.
Cross-functional teamwork with Production Quality and R&D teams.
Key Responsibilities:
Validation Leadership: Execute and document IQ/OQ/PQ/MSA protocols for equipment processes test methods and computerized systems.
Compliance & Audits: Serve as the primary point of contact for external audits ensuring adherence to FDA (21 CFR 820) ISO and cGMP standards.
Process Improvement: Lead Lean Six Sigma initiatives (e.g. scrap/defect reduction) and strategic projects for new technology implementation.
Cross-Functional Collaboration: Partner with Production Quality and R&D teams to align on quality initiatives and root-cause investigations.
Technical Expertise: Utilize engineering tools (CAD Minitab) and analyze data to support continuous improvement and validation efforts.
Mentorship: Guide junior engineers and provide technical support for design qualification and process monitoring.
Work Environment & Physical Demands:
Physical: Light lifting (up to 10 lbs.) sitting/standing/walking.
Conditions: FDA-regulated manufacturing facility; PPE (e.g. smock) required.
Education: Bachelors degree in Engineering.
Experience: 3 5 years in Quality Engineering preferably in FDA-regulated/Medical Device industries.
Regulatory Knowledge: FDA cGMP ISO ASQC and change control processes.
Preferred Education & Experience
Education: Masters degree in Engineering.
Certifications: Lean Six Sigma (Green/Black Belt).
Required Technical Skills
Execution of IQ/OQ/PQ/MSA protocols for equipment processes and test methods.
Experience with computerized system validations.
Knowledge of FDA cGMP (21 CFR 820) ISO standards and ASQC requirements.
Experience in change control processes and audit readiness.
Proficiency in statistical software (e.g. Minitab) for data analysis.
Ability to perform Root Cause Investigations (RCI) and corrective actions.
Ability to read/interpret blueprints and technical drawings.
Familiarity with CAD or similar engineering tools.
Application of process improvement methodologies (e.g. scrap/defect reduction).
Experience developing/deploying Quality Systems in regulated environments.
Microsoft Office Suite: Advanced skills in Word Excel PowerPoint and Access.
Database Management: Ability to organize and analyze large datasets.
Required Soft Skills
Ability to present complex technical information clearly (written/verbal).
Experience defending validation projects during external audits.
Ability to prioritize tasks manage multiple projects and meet deadlines.
Mentorship of junior engineers.
Cross-functional teamwork with Production Quality and R&D teams.
Key Responsibilities:
Validation Leadership: Execute and document IQ/OQ/PQ/MSA protocols for equipment processes test methods and computerized systems.
Compliance & Audits: Serve as the primary point of contact for external audits ensuring adherence to FDA (21 CFR 820) ISO and cGMP standards.
Process Improvement: Lead Lean Six Sigma initiatives (e.g. scrap/defect reduction) and strategic projects for new technology implementation.
Cross-Functional Collaboration: Partner with Production Quality and R&D teams to align on quality initiatives and root-cause investigations.
Technical Expertise: Utilize engineering tools (CAD Minitab) and analyze data to support continuous improvement and validation efforts.
Mentorship: Guide junior engineers and provide technical support for design qualification and process monitoring.
Work Environment & Physical Demands:
Physical: Light lifting (up to 10 lbs.) sitting/standing/walking.
Conditions: FDA-regulated manufacturing facility; PPE (e.g. smock) required.
Employment Type
Full Time
Key Skills
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