Director of Quality Assurance Not right for you? We've got others

$115,000 - $185,000
Waco, Texas
January 11th 2023
Minimum Degree:
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Job description:

Director of Quality Assurance - Medical Devices

This position will lead all Quality Assurance functions between two medical device production facilities. The two facilities consist of a production plant in Taiwan as well as a new production plant in Central Texas. The facility in Central Texas is currently under construction and will be the base location for this position. Some travel to Taiwan will be necessary.

The Director of Quality Assurance (QA) Manager is responsible for the development of new quality standards and operating protocols. Leading a team of 4-6 employees, they are tasked with ensuring and maintaining the overall effectiveness of the Site Quality Program. This includes, but is not limited to complying with ISO 13485 and 21 CFR 820 to verify product standards are met. The Director of QA will also be the lead contact for all government regulatory agencies, include the FDA and ISO. A strong candidate will have experience as a lead for FDA inspections and audits.




- High level of organizational skill is required.

- Ability to work independently, in a fast paced, high-pressure environment.

- Advanced knowledge of ISO 13485 as well as 21 CFR 820

- Advanced knowledge of Microsoft Excel, Word, and Outlook.

- Advanced communication and problem-solving skills.


- 4-year college degree (Bachelors) in Science, or equivalent.

- 5+ years experience in regulatory affairs, product development, or product manufacturing in a Management capacity.

- Six Sigma Certification a plus

- Lean Manufacturing Certification a plus

- ISO Lead Auditor Certification a plus

Why is This a Great Opportunity:

Our client company is an international market leading medical device company focusing exclusively on Class 1 products.The company has a strong 50 year presence in the industry and is experiencing rapid growth. They are constructing a new production facility in Central Texas to offset overseas production. This is an opportunity to build a process and team from the ground up. This position will be responsible for developing a full site plan as well as having significant input on their team. Great opportunity to work for a great company in a very high demand location!

Salary Type : Annual Salary

Salary Min : 115000

Salary Max : 185000

Currency Type : US Dollars


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