In Process Quality Engineer

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Summary

• 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:

Job Type:

Work Shift:

Pay Rate Type:

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.