Staff Design Control Engineer
Country:
Malaysia
Location:
Penang, MY
City:
Penang
Business Area:
R&D
Employment type:
Full-time
Responsibilities:
- Process document ownership / expertise for Life Cycle Management (LCM) activities with in-depth understanding of DMR and DHF from Design Control perspective.
- Ensure design control process and documentation alignment with stakeholders in design changes for LCM.
- Review/ Approve documents and sign-off on DCO's, SCO's etc. for LCM activities specified in Quality Management System.
- Have technical understanding of the product (but not technically responsible).
- Have good overview of DCR and product document matrix.
- Provide coaching and facilitation for Change Handlers in relation to documentation strategy and activity planning.
- Align the way of working in design changes documentation across Solutions and supporting functions for good documentation practice.
Requirements:
- Masters or Bachelor's Degree in Mechanics / Material or equivalent Engineering and find it easy to understand challenges in other professional areas.
- Minimum 3 years' experience in product engineering environment and how to ensure a stable and reproducible assembly manufacturing processes. Experience with quality system and quality engineering.
- Advantage if he / she has relevant experience preferably from Medical Device industry, including Design Control practice and Design Changes implementation.
- Open mind for new and sharing knowledge, experiences and work processes. Team player and drives with high sense of urgency.
- Demonstrates excellent interpersonal communication, organizational, coordination, and problem-solving skills, especially in cross-functional teams.
- Be proficient in written and spoken English at negotiation level. Good interpersonal skills.
- Work independently, structured and systematic. Able to work in a cross-cultural team.