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Summary
Your Role –
Production Monitoring: Conduct stage-wise, patrolling inspections on the production floor to ensure adherence to standard operating procedures (SOPs) and control plans.
Inspection & Testing: Use precision measuring instruments (e.g., Vernier, micrometer, height gauge, CMM) to check dimensions, visual appearance, and material properties. Proficiency in reading engineering drawings, GD&T (Geometric Dimensioning and Tolerancing), and using inspection tools.
Defect Analysis & CAPA: Identify, document, and analyze defects, performing root cause analysis (RCA) using tools like Fishbone, 8D, or Why-Why analysis.
Documentation & Reporting: Maintain inspection reports, control plans, and calibration records for measuring equipment.
Process Improvement: Drive continuous improvement initiatives such as 5S, Kaizen, and Statistical Process Control (SPC) to minimize waste and rejections.
Compliance & Auditing: Ensure compliance and support internal/external audits, perform Internal Process Audits.
Quality Tools: Knowledge of 7 QC tools, APQP, PPAP, and FMEA.
Soft Skills: Strong analytical, problem-solving, and communication skills.
Good to Have
• Documents work/deliverables according to the company standards and ISO 13485 and FDA regulations.
• Greenfield Project experience
Job Description
Your Role –
Production Monitoring: Conduct stage-wise, patrolling inspections on the production floor to ensure adherence to standard operating procedures (SOPs) and control plans.
Inspection & Testing: Use precision measuring instruments (e.g., Vernier, micrometer, height gauge, CMM) to check dimensions, visual appearance, and material properties. Proficiency in reading engineering drawings, GD&T (Geometric Dimensioning and Tolerancing), and using inspection tools.
Defect Analysis & CAPA: Identify, document, and analyze defects, performing root cause analysis (RCA) using tools like Fishbone, 8D, or Why-Why analysis.
Documentation & Reporting: Maintain inspection reports, control plans, and calibration records for measuring equipment.
Process Improvement: Drive continuous improvement initiatives such as 5S, Kaizen, and Statistical Process Control (SPC) to minimize waste and rejections.
Compliance & Auditing: Ensure compliance and support internal/external audits, perform Internal Process Audits.
Quality Tools: Knowledge of 7 QC tools, APQP, PPAP, and FMEA.
Soft Skills: Strong analytical, problem-solving, and communication skills.
Good to Have
- Documents work/deliverables according to the company standards and ISO 13485 and FDA regulations.
- Greenfield Project experience
Your Profile:
- Bachelor in mechanical engineering/Medical Engineering
- 5+years in process quality experience in Automotive or Medical Manufacturing companies
- Ability to multi-task effectively
- Proactive problem-solving mindset.
- Work from Office
SKILLS, KNOWLEDGE AND CERTIFICATIONS
Required Certifications and Training
- Obtains and completes LMS training plan specific to assigned responsibility.
Experience Level with Business Tools
- Proficient in utilizing business tools such as: E-mail, Microsoft Word, Excel, and PowerPoint.
- Experience with SAP or equivalent ERP product and productivity software desired.
LEVEL DESCRIPTION
Knowledge
- Developing professional skills and experience.
Job Complexity
- Works on problems of diverse scope where analysis of situations or data requires a review of a variety of factors. Exercises independent judgment and discretion in solving complex business problems.
Interaction
- Builds productive internal/external working relationships.
Supervision
- Normally receives general instructions on new projects or assignments.
Typical Education and Experience
- Bachelors Degree (or equivalent experience)
- and/or 2-5 years of related experience or Masters Degree with no or little experience.
ENVIRONMENT AND PHYSICAL REQUIREMENTS
Environment and Physical Demands
- As described in the job posting
Ability to Travel
- Travel may be required. See the job posting for more information.
Time Type:
Full time
Job Type:
Regular
Work Shift:
N/A
Pay Rate Type:
Salary
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
