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Quality Engineer

Posted: 06/18/2020

Join our company and have the opportunity to work in the medical device industry.  Our overall company mission is to provide custom precision manufacturing and innovative services to medical, aviation, space and defense and emerging high tech industries.  We offer our employees competitive wages and benefits with the opportunity to grow and advance their careers. Our work environment is clean with a focus on safety. 

This position is responsible for working with cross functional teams to lead process validation and capability studies and perform other advanced quality activities to support internal and external customer requirements.
This position may participate in one or more of the following duties as directed by supervision or management.

Monitor processes for changing validation needs and maintain a master validation plan.
Write validation protocols, coordinate execution, and write reports for IQs, OQs, and PQs
Evaluate new equipment and fixtures and determine their impact on validation.
Provides support and assures cGMP compliance in product and process validation and process transfers.
Develop test methods for new specifications and/or equipment.
Assist in the maintenance of process FMEAs.
Develops and leads execution of gage, process, and machine capability studies.
Determines quality improvement parameters by identifying statistical methods relevant to manufacturing processes.
Prepares reports by collecting, analyzing, and summarizing data; making recommendations using standard statistical techniques.
Apply standard engineering techniques to assigned tasks and ensure that specific goals are met in terms of quality, quantity, and timeliness in order to meet company goals.
Assist with root cause analysis with accountability to resolve or initiate plans to ultimately resolve these problems.
Other miscellaneous duties as assigned.
Responsible to conduct yourself and ensure your subordinates (if applicable) conduct themselves in a manner consistent with company mission, values, code of ethics, policies, and other standards of conduct.

Bachelors or Associates degree in Engineering, Quality, Life Sciences or related field preferred. 
Certification as a Quality Engineer (Eg CQE) or the Reliability Engineer Certification (CRE) granted through the American Society of Quality (ASQ) preferred
3-5 years related Quality or Manufacturing Engineering experience in a regulated industry.
Demonstrated experience with Quality Tools.
Proven project management experience. 
Experience working in a manufacturing environment
Strong written and verbal communication skills.
Ability to multi-task, analyze, and learn/understand industry terminology.
Should have a hands-on learning attitude.
Statistical skills
Regulatory, cGMP, ISO knowledge base
Knowledge of Microsoft Office including Word, Excel, Access, and Outlook
Personnel performing acceptance activities of product shall have natural or corrected near-vision acuity of 20/20 in at least one eye per Titmus screening or equivalent.
Knowledge of Six Sigma highly desire.
Minitab a plus.

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