- Location
- Penang,MY, MY
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
- Education
- Bachelor
- Source
- Eightfold
Description
Selects appropriate techniques for problem solving and makes solid and consistent Engineering and Quality Assurance recommendations. Read and interpret technical drawings, procedures, and protocols. Has the responsibility and independent authority to make decisions related to product quality, including the disposition of non-conforming product. Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria. Participates in Customer Complaints investigation for areas under their control. Document investigation findings in analysis report on GCS2. Become a trainer for the Software related with complaints handling process (GCS2), as required. Bachelor's Degree in Engineering, Technology, or related Science. Minimum 4 to 5 years of relevant experience in a regulated industry, preferably within the medical device industry. Experience in reviewing and approving nonconforming event risk assessments and investigations. Strong understanding of quality systems, regulatory requirements, and validation processes. Strong analytical mindset with proven problem-solving capability. Good understanding of ISO 13485 requirements and QMS regulations. Experience running and reviewing nonconforming event risk assessments and investigations. Experience executing and supporting the full validation lifecycle, from planning to reporting. Strong analytical skills, problem-solving skills, including Root Cause Analysis (RCA). Statistical analysis skills using tools such as Excel and Minitab. CAPA, NCEP, Failure Mode Investigation, and nonconformance management. Validation engineering and process validation expertise. Customer complaint investigation and complaint handling experience. Technical documentation review and approval. Effective communication and cross-functional collaboration skills.
