Job Description

Position Summary:

Nextern, an US based innovator in developing and manufacturing class II & III electro-mechanical medical devices is seeking a IPQC Senior Engineer for its Ho Chi Minh, Vietnam location. Join an organization with a passion for commercializing smart, effective and patient centric medical device solutions.

Our IPQC Senior Engineer is a key organizational part of the operations management and continuation engineering teams. Specifically, In Process Quality Control (IPQC) is key to establishing and sustaining our business culture of continuous improvement by leveraging data to improve processes, eliminate waste, and compel the business and our customers to take action. We enable business growth by developing quality professionals in the areas of predictive engineering, lean six sigma, root cause analysis, issue investigation, and process control.

This position is responsible for quality control of all incoming inspection, product manufacturing assembly lines and production processes between Nextern and key customers in the Integrated Systems business. The IPQC Senior Engineer will be a key part of operating global requirements of our day-to-day performance in engineering, manufacturing, and supply chain, while balancing accountability between both companies to achieve exceptional product quality performance in compliance with government and regulatory agency requirements and directives.

Job Description:

The following processes are key to IPQC performance within Nextern and between Nextern and our key customer 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. Manage CAPA (Corrective Action Preventive Action) on molding production line.
2. Evaluate the Process Qualification & Validation.
3. Manage all activities of quality inspectors.
4. Make sure production lines follow manufacturing procedures and production operators are trained when working on lines.
5. Process Control & Yield/Trend Monitoring of other products.
6. Return Material Authorization (Customers to Nextern).
7. Failure Analysis of Returned Products (Out of Box & Fielded).
8. Manage all non-conforming on the production lines
9. Create required documentations that are relevant to product specifications and requirements when manager assign (Process flow, control plan, inspection criteria, etc.)
10. Manage inspection of out-going shipment

Requirements

Knowledge, And Skills

1. Problem Solving - The ability to identify problems and develop and implement solutions to the issues.
2. Decision Making - The ability to make "value added" decisions in a timely manner at all levels of the organization.
3. Strategic Thinker - The ability to creatively develop effective responses and plans to people, problems or issues.
4. Communication Skills - The ability to effectively communicate ideas, arguments, solutions and work through conflict resolution at all levels of organizations both internally and externally.
5. Negotiation - The ability to plan for, implement and communicate the "elements of negotiations" that create value for Nextern, while maintaining supplier relationships.
6. Ethics - Consistently uses good judgment when analyzing right and wrong and performs at a level of conduct that is within corporate ethics guidelines.
7. Have knowledge about ISO 9001:2015 (ISO 13485:2016 is preferable).
8. Understand the process flow and quality control plan.
9. Have knowledge of FMEA.
10. Have knowledge in process capability and control, Minitab.
11. Understand the drawing requirement and AQL level requirement.

Qualification:

1. Requires a bachelor’s degree or higher in the Engineering field (Mechanical, Electrical Engineering preferred) or related technical degree.
2. 5+ years' experience Quality. Regulatory Compliance submissions of Class I and Class II medical devices is preferable.
3. Extensive knowledge of FDA Medical Device Regulation is preferable.
4. Excellent verbal and written communication skills in English Language.
5. Oral and Written Communication Skills - Speaks clearly and persuasively in positive or negative situations. Listens and gets clarification; responds well to questions. Demonstrates group presentation skills. Participates in meetings. Writes clearly and informatively. Edits work for spelling and grammar. Varies writing style to meet needs. Presents numerical data effectively. Able to read and interpret written information.
6. Computer Skills - To perform this job successfully, an individual should have knowledge of MS Office and the ability to read and interpret mechanical, Electrical and Electro-Mechanical drawings and models.

Benefits

1. Benefits Competitive salary
2. Professional and Friendly Working Environment, chance to attend employee's training and development programs
3. Premium healthcare Insurance (In Vietnam) & Business travel insurance Health, social & unemployment insurance (following Government regulation)
4. Company trip, New Year party, Team building
5. Occasion-based offerings: Birthday, New year, Mid-Autumn, Labor Day, etc.