The following processes are key to Supplier Quality Engineer performance within Nextern and between Nextern and our key supplier collaborators. This role must be proficient at achieving outcomes on time, with high quality documentation content, and cross-functional team awareness/support (internal & external).
1. Control suppliers follow knowledge of quality systems including ISO, Six Sigma and TQM.
2. Be responsible for Supplier Development
3. Implement the supplier performance evaluation, qualification
4. Be Supplier corrective action request (SCAR) lead.
5. Conduct the supplier audits and inspections
6. Experience with varied mechanical production processes for plastics and metals.
7. Experience in preparing CpK, PpK, PPAP documentation
8. Experience in working with inspection equipment, such as CMM, Optical Comparator and other mechanical measuring devices.
9. Hands on experience in performing assessment of production processes to determine compliance with requirements/specifications, documentation and reporting.
10. Can capture the failure mode in IQC and evaluate the failure risk; Manage MRB for non-confirming parts in IQC.
11. Have the ability to identify process issues and work with suppliers to correct product deviations
12. Supervisory Responsibilities: Oversees multiple subordinates and suppliers. Responsibilities include planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems
13. Perform other assignments as requested.
Requirements
Knowledge And Skills
1. Have knowledge about ISO 9001:2015; ISO 13485:2016 is preferable.
2. Understand the drawing requirement and AQL level requirement.
3. Experience in Solving Problems (follow 8D).
4. Have knowledge of FMEA.
5. Have knowledge in process capability and control, Minitab.
6. Problem Solving - The ability to identify problems and develop and implement solutions to the issues.
7. Decision Making - The ability to make "value added" decisions in a timely manner at all levels of the organization.
8. Communication Skills - The ability to effectively communicate ideas, arguments, solutions and work through conflict resolution at all levels of organizations both internally and externally.
9. Ethics - Consistently uses good judgment when analyzing right and wrong and performs at a level of conduct that is with in corporate ethics guidelines.
Qualification:
1. Bachelor’s degree or higher (Prefer candidate have experience in medical device).
2. Minimum 2 years’ experience in Supplier quality management.
3. Good in excel (especially VBA), word and PowerPoint.
4. Language: must be good in English (written & speaking).
5. Good presentation and communication, especially in English.
6. Leadership behavior is preferred.
7. Knowledge about improving concepts (Kaizen, 6 sigma, lean manufacturing, etc.) is preferable
Benefits
- Competitive salary
- Professional and Friendly Working Environment, chance to attend employee’s training and development programs
- Premium healthcare Insurance (In Vietnam) & Business travel insurance
- Health, social & unemployment insurance (following Government regulation)
- Company trip, New Year party, Team building
- Occasion-based offerings: Birthday, New year, Mid-Autumn
Top Skills
What We Do
Nextern collaborates with innovators, clinicians, and device partners to create, iterate, optimize and manufacture best-in-class medical devices. We bring an unmatched core competence in medical device product design and development through manufacturing as a leverageable asset to collaborators like you, who are focused on accelerating the commercial side of the business.
