QA Specialist/Change Analyst
Natus Medical Incorporated - Mundelein, IL

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About Natus Medical Incorporated: Natus is a leading provider of healthcare products used for screening, detection, treatment, monitoring and tracking of common medical ailments such as hearing impairment, neurological dysfunction, epilepsy, sleep disorders, newborn jaundice and newborn metabolic testing.

Job Summary: Responsible for independently driving and/or championing quality systems and related projects including, but not limited to: improving current training system, change control processes, quality tracking systems.

Essential Duties and Responsibilities: S tay up-to date and follow all Quality System procedures related to this job, which can affect the quality of products or services provided to our customers. Responsible for maintaining controlled document system. Responsible for supporting internal audit system. Responsible for supporting/maintaining training system. Provide back up support to other plant quality control/systems functions. Supports audits and regulatory authority inspection preparation.

Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience: Bachelor's degree (B.A.) from four-year college or university; or two to four years related experience and/or training; or equivalent combination of education and experience. Experience in the medical device or pharmaceutical industry required. Current knowledge of FDA and international quality system requirements required. Experience in international regulations preferred. Experience with Agile PLM preferred.

Certificates, Licenses, Registrations: Certification by ASQ as certified quality auditor (CQA), quality engineer (CQE) preferred.

Other Skills and Abilities: Knowledgeable in Project Planning; Statistical Analysis of Quality Data; software validation, the Food and Drug Administration’s Quality System Regulations (FDA’s QSR), International standards such as ISO 13485:2003, ISO 14971:2007; Medical Devices Directive (MDD), Canadian Medical Device Regulations (CMDR).

Location: Mundelein, IL 60060

Status: Full Time

Natus Medical Incorporated is an EOE, M/F/D/V

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You may also fax your resume to (847) 949-8615 Attn: HR, referring to the Job Title.

No calls please, principals only and only local candidates will be considered.

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Natus is a leading provider of healthcare products used for the screening, detection, treatment, monitoring and tracking of common medical...