Quality Manager
Seeking a quality manager with experience in FDA, ISO13485, and MDD regulated quality system for medical device and software application business.
The successful candidate will have the following skills/experience:
Bachelor’s degree in a technical area or equivalent industry experience
FDA/ISO audit experience
3-5 years experience in medical device quality system design/maintenance
Design control
Hands on quality lead
Good documentation skills
Ability to adapt to a changing environment
The company offers a competitive salary/benefits, growth opportunities.

This position is open at the company I work for. Looking for someone who can lead the effort in terms of internal compliance and work with external sources as well. Such as our ISO representatives and FDA. 510(k) experience for class 2 devices a plus.

The company is an equal opportunity company.

The position reports to the VP Product Development.

Thanks,

Frank K.
VP Product Development.

Please em me at Sekamed@att.net (Sekemed@att.net)

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