Senior Supplier Quality Engineer (SQE)

Senior Supplier Quality Engineer (SQE)

Agensi Pekerjaan EPS Consultants Sdn Bhd
6-9 years
Not Specified

Job Description

Location: Kamunting, Taiping
Headcount: > 1500
Tenure: Permanent
Job Responsibilities
  • Provide supplier quality engineering support for Product and process transfer program, ensuring that all activities are completed and documented in accordance with transfer objectives.
  • Application of a prioritized approach in achieving key opportunities in quality, service and cost.
  • Support the development and implementation of appropriate supporting documentation, SOPs and process work instructions compliant with current Good Manufacturing Practices (GMP)
  • Conduct Gauge R&R studies for supplier quality process between sending and receiving sites.
  • Transferring and implementing processes, from the sending to receiving facility.
  • Provide Supplier Quality support for Process validation for products and processes; VP, IQ, OQ, PQ and associated documentation.
  • Responsibility for projects work streams as assigned by the company, including the scoping, approval, budgeting, specification, execution, qualification and handover as appropriate.
  • Actively interfacing with cross-functional team members and 3rd party Vendors, and always practicing good teamwork in support of the day to day operating requirements, and in pursuit of achieving the project and business targets
  • Perform supplier facility compliance audits
  • Ensure compliance with each company's procedures, cGMP, recognized quality standards and regulatory expectation
  • Take part in knowledge-transfer activities, including collaborative meetings with other groups
  • Proven Project Management skills through the delivery of business-critical projects.
  • Strong communication and influencing skills with both internal and external agents.
  • Capable of technical leading, influencing and providing technical direction to Engineers, Co-Op Students, Technicians and Operators as required.
  • Capable of working as part of a multi-disciplined team in a dynamic and results motivated environment
  • Demonstrable analytical & problem-solving skills, a process improvement orientation, and the ability to handle multiple tasks in a fast-paced and results-oriented environment
  • Demonstrable ability to work autonomously
  • A team player, with a flexible approach.
  • Confident and effective decision maker, with a proven ability to negotiate and influence others.
  • Provide Lead Auditor accountability within the audit program.
  • To serve as subject matter expert in the area of problem-solving methodologies.
  • Provide training to different levels of the organization on problem solving methodologies/root cause analysis and to develop investigation skills.
  • Provide other departmental support requested by immediate supervisor.
  • Adhere to and ensure the compliance of Teleflex Code of Conduct, all Company policies, rules, procedures and housekeeping standards.
  • To ensure the implementation and maintenance, within the department, of an effective management for occupational safety and health consistent with the Occupational Safety and Health Act 1994 and other legislative requirements.
  • Ensure Program conforms to the Quality System Regulation (QSR), CMDCAS, MDD 93/42/EEC, ISO 13485 and other relevant Standards.

Education / Experience Requirements
Bachelor degree in Science, Engineering or any other technical discipline
  • Prefer 7-10 years of experience working within regulated industries. Process Engineering experience is highly desirable for the role
  • Product and Process Transfer Experience is desirable
  • Molding Experience highly desirable.
  • Advanced problem solving and root cause analysis.
  • Subject Matter Expert in Purchasing Controls.
  • Advanced statistical techniques knowledge.
  • Minimum 5 years of Lead Auditor experience.
  • Advanced knowledge of ISO 13485 & QSR 21 CFR Part 820
  • 3rd party auditor/engineering certification highly desired

Job Details




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