Senior Quality Engineer

tecomet, inc

Penang, Malaysia

4-6 Years

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Posted 8 days ago
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Job Description

Position Summary

The Quality Engineer I will interact with team members to ensure compliance and internal and external customer requirements are met, with focus on quality engineering. This will be accomplished within Tecomet's principles of continuous improvement, customer driven innovation and a win first culture, while meeting company financial and other performance metrics.

Principle Responsibilities

Must demonstrate a working knowledge of standard manufacturing operations, FDA and ISO regulations.
Standard problem-solving techniques to investigate customer complaints including associated actions including CAPA, deviations, and complaint responses.
Ensures that manufactured products consistently meet customer specifications, regulatory requirements, and internal quality standards, while supporting operations to prevent defects, reduce risk, and drive continuous improvement.
Drive risk-based thinking and defect prevention
Support lean, yield improvement, and cost-of-poor-quality reduction
Prepare DCP/FMEA's, controls plans, quality plans, PPAP.
Supporting the MRB and RMA processes.
Work with team members and support manufacturing/operations to solve quality, cost and schedule issues.
Works with Internal and External Customers.
Ensure all transfers and NPI for products assigned is well managed meeting 100% first article inspection (FAI) and timelines for startups (where applicable)
Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) requirements.
Participates in audits and inspections.
Applies statistical and Six Sigma concepts and techniques. Use data (SPC, trends, KPIs) to influence operational decisions
Special projects as assigned by quality management.

#QA2

Credentials/Experience

Qualification Requirements

Bachelor's Degree in Engineer or related field. Or a minimum of 4 years experience within the Medical Device Industry, and Certification (ASQ CQE or CMQ/QE)

Experience/Educational/Training Preferred

ASQ CQE or CMQ/QE preferred
2 years experience in quality within medical device manufacturing industry preferred

Knowledge, Skills, And Abilities

Quality Systems ISO 13485 and customer interaction experience preferred. Knowledge of AS9100 is an advantage.
Regulations knowledge of 21CFR820 and GMP knowledge
Understanding of Risk management (ISO 14971 concepts)
Validation & process capability (Cp/Cpk)
GD&T, drawings, inspection methods, Metrology.
Problem solving skills and ability to use tools such as 8D.
Statistical tools & data analysis experience
Microsoft office (Word, Excel, Outlook, PowerPoint).
Manufacturing operations - forging and/or machining (advantage)

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled

More Info

Job Type:

Permanent Job

Industry:

Other

Function:

Medical Device Industry

Employment Type:

Full time

About Company

tecomet, incJob Source: www.linkedin.com

Job ID: 147564651

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Last Updated: 20-05-2026 01:20:39 AM

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