Engineer QA
Job Summary
Job Description
JOB SUMMARY
1. Project management and development with process validation experience;
2. Quality issue handling;
3. Production & Process audit
Quality engineer is an essential support role for certain division in Medline. He/She will be providing suggestion or comment from quality perspective for other department (i.e QA, PM, or Sourcing) to contribute in completion of all assigned project
CORE JOB RESPONSIBILITIES:
1. Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.
2. Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable quality.
3. Work with other functional team (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.
4. Lead the sample evaluation, process validation, and performance testing during the new product development phase. And fulfil the technology transfer to SQE/QC team.
5. Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.
6. 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.
7. Work with Suppliers and Company corporate office in US to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
8. Work with suppliers and Company QC team in Asia to reduce product rejections.
9. Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.
10. Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.
BASIC QUALIFICATIONS:
Education
B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.
Relevant Work Experience
3+ years of engineer experience, project management is preferred
on process control and quality control is required
Additional
Understanding of quality system requirements (ISO 13485 or ISO 9001)
Excellent English speaking, reading and writing skills.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
Weβre dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Apply To This Job
Job Description
JOB SUMMARY
1. Project management and development with process validation experience;
2. Quality issue handling;
3. Production & Process audit
Quality engineer is an essential support role for certain division in Medline. He/She will be providing suggestion or comment from quality perspective for other department (i.e QA, PM, or Sourcing) to contribute in completion of all assigned project
CORE JOB RESPONSIBILITIES:
1. Ensure suppliers are clear on all Company and International standards, processes and procedures as they relate to various medical devices.
2. Perform in line and finished product verification in accordance with Company and International Standard to ensure acceptable quality.
3. Work with other functional team (QA and PM) to determine appropriate testing parameters for the products to ensure limited failures in product.
4. Lead the sample evaluation, process validation, and performance testing during the new product development phase. And fulfil the technology transfer to SQE/QC team.
5. Perform process audits and identify opportunities for continuous improvement on process control, production control and quality control.
6. 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.
7. Work with Suppliers and Company corporate office in US to help resolve various customer complaints. Specifically, help with root cause investigations and analysis. Implement CAPAs based on root cause investigations to reduce complaint numbers. Ensure that solutions to quality issues are properly implemented and upheld.
8. Work with suppliers and Company QC team in Asia to reduce product rejections.
9. Work with suppliers to identify opportunities for product and process improvements that lead to cost savings.
10. Work with supplier to validate and optimize the production parameters and ensure suppliers properly document and verify these parameters once implemented.
BASIC QUALIFICATIONS:
Education
B.S. Degree in Mechanical Engineering, or Material, or Industrial engineer or Medical device related engineering field required.
Relevant Work Experience
3+ years of engineer experience, project management is preferred
on process control and quality control is required
Additional
Understanding of quality system requirements (ISO 13485 or ISO 9001)
Excellent English speaking, reading and writing skills.
Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.
Weβre dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.
Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.
Apply To This Job