Quality Engineer

Job Summary:

Quality Engineer is an essential individual role for product development until the first mass production. The main work include but not limit to: supplier quality capability assessment, project milestone set-up, guidance to suppliers on tooling, samples, validations and or production line set-up, quality problem-solving and design change control.

Job Responsibilities:

1. Ensure suppliers are clear on all Medline and International standards, processes and procedures.

2. Perform in line and finished product verification in accordance with Medline and International Standards to ensure acceptable quality.

3. Work with other functional teams (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.

4. Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.

5. Be responsible for projects with vendors from a quality perspective, more specifically, on product design change, quality performance improvement, and monitoring quality performance on critical products.

6. Work with suppliers and QC team in Vietnam to reduce product rejections, and work with SQE team to reduce complaints.

7. Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.

8. Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.

Qualifications:

• B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.
• 3+ years of engineer experience, project management is preferred
• Excellent English speaking, reading and writing skills.
• Process audit skills and quality system auditor will be preferable

BASIC Technical Skills: List essential abilities in practical & technical knowledge which are required to perform the job.

• Knowledge and experience of on-process control and quality control is required Good data analysis skills, utilizing data to dig up and solve problem;
• Understanding of quality system requirements (ISO 13485 or ISO 9001)
• Ability to read and interpret product specifications and drawings
• Detail oriented with strong written and verbal communication, problem solving, and organizational skills
• Professional attitude with a heightened sense of urgency to complete tasks accurately and efficiently.
• Ability to effectively recognize and suggest improvements for finished products, processes and documentation practices to suppliers, managers, and coworkers.
• Proficiency of PC skills: AutoCAD or SolidWorks, MS Word, MS Excel, Adobe and E-mail
• Available to travel frequently.
• Capable of handling special projects as directed by Managers.

Core Competency (MSF): Applicable to all openings.

Focus on the customer

Sound judgement

Deliver results

Sense of urgency

Strong work ethic

Build effective relationships