Quality Engineer

Job Location: 
New Berlin, WI

Ready for a new challenge, and motivated to make an impact working for a leading global company? If you want to grow your career and fill an important position, then you could be what our client is looking for in their Quality Validation Engineer. This role will ensure quality and consistency of products by establishing product inspection criteria and methods, as well monitoring internal product quality. This position will also maintain validation policies and procedures, and will lead validation exercises to ensure compliance with global regulations and company standards. Reports to the Manager of Quality. Great opportunity with a respected and stable company that offers a competitive compensation and benefits package.  If this is for you or someone you know, please forward a current resume to tim@pointonerecruiting.com

 

Job Responsibilities-Quality/Validation Engineer:

Schedule and execute validation activities, including validation test plans and follow-up on closure documentation for IQ, OQ and PQ validation.

Provide validation support for new or modified software or equipment used to manufacture medical devices or meet quality system requirements.

Manages validation-quality projects

Confirms system and process capabilities by designing feasibility studies and test methods.

Ensures documents are controlled by acting as a system administrator for Solidworks PDM document control software, and understanding and communicating FDA document control requirements.

Facilitates internal training record processes for QMS. 

Supports post-market compliance, including customer complaints.

 

Requirements and Experience-Quality/Validation Engineer

Bachelor’s Degree from college or university with minimum of 2 years’ related experience, or associate degree and 5 years’ minimum related experience. Minimum of 5 years’ related experience in validation and risk assessment preferred.

ISO 13485 internal auditor certification preferred.

Excellent communication and project management experience required.  

 

Apply Now!  Send resumes to tim@pointonerecruiting.com

Recruiter Name: 
Tim Borop
Recruiter Phone: 
(262) 886-8000 ext. 218
Category: 
Manufacturing & Engineering

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