Senior Quality Engineer

Headcount : 1

Senior Quality Engineer

Key Responsibilities

• 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.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Demonstrates and actively promotes highest levels of professional QA engineering discipline and rigor.
• Is viewed as a leader in the areas of QSR and ISO / MDD standards within one’s own group, constantly promoting awareness of best industry practices and making appropriate decisions on a daily basis using the Quality Engineering Manager / Site QA Director as the final arbitrator on critical quality decisions.
• Has significant expertise in validation engineering and is thoroughly familiar with all regulatory requirements.
• Checks and provides support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
• Reviews and approves operational, test and validation data to establish technical specifications and performance standards for newly designed or modified products and processes.
• Champions continuous improvement and innovation from a quality perspective within the department right from vendor selection / approval through to customer awareness / satisfaction.
• Is an effective team member, fully motivated to achieve and demonstrate best practices in line with the department and LRP objectives.
• Gives technical guidance to Quality Engineers, Associate Quality Engineers, technicians and inspection staff.
• Works with EHS to identify significant environmental impacts of Boston Scientific operations and to establish goals and targets around significant environmental impacts.
• Deals with suppliers, other engineering disciplines within and outside of the site and customers as needed.
• Is familiar with the internal auditing process.

Requirements

Sub Specialization : Engineering;Others

Type of Employment : Permanent

Minimum Experience : 5 Years

Work Location : Penang

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