Quality Engineer - Supplier Quality

Natus Medical Incorporated Middleton , WI 53562

Posted 3 months ago

About Natus:

Natus Medical is a leading manufacturer of medical devices for the Newborn Care, Neurology, Sleep, Hearing and Balance markets since 1989. Natus products are used in hospitals, clinics and laboratories worldwide. Our mission is to improve outcomes and patient care in target markets through innovative screening, diagnostic and treatment solutions. Now we're undergoing one of the biggest transformations in our history: OneNatus. In almost every area of Natus Medical, we're shaking things up and looking for new ways to develop and deliver a great experience for our employees, customers and patients.

It means there's a lot happening but it's an exciting time to be part of our team. So, if you have the drive, optimism and resilience to help drive us forward, we'll offer a ton of opportunities to learn and experience new things. If that's you and what you're looking for, we'd love you to be part of our future.

Job Summary:

The Quality Engineer is responsible for the assurance of the quality system; adherence to inspection and GMP; and for compliance of the Quality System. This role can expect to focus on supplier audits.

In this job, you will:

  • Provide quality engineering support to designated areas such as: providing support to change requests, product and process validation, non-conforming product issues, Corrective and Preventive Action program, Design and Process FMEA, risk assessment and associated Quality System Documentation.

  • Facilitate in the Supplier & Internal Quality Audits program as an auditor and support Regulatory Audits and Customer audits as required.

  • Provide Quality Engineering support to Incoming Quality Control, In-Process and Final Quality release activities.

  • Ensure compliance with all applicable domestic and international regulatory requirements and quality system regulations and standards associated with product manufacture and release.

  • Coordinate Sterilisation programme for sterile products (including Dose audit program) and process validation.

  • Provide input and support to the Corrective and Preventive Action program (CAPAs), Complaint Handling, Non-Conforming Product and MRB Process.

  • Participate in CAPA activities such as root cause analysis, corrections, corrective action plans and effectiveness verifications. Enters and updates data within the CAPA database, providing routine status reports and updates on current CAPA system activities to management on a routine basis.

  • Complete Risk assessment of customer complaints, Non-conformance and CAPA's.

  • Complete Gap review and Create or update QMS procedures in support of the quality system and product lines for which the QE has responsibility for

  • Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

  • Support the activities associated with preparing the QMS to maintain certification to MDSAP (FDA, CMDR, ANVISA and other regulations) as well as ISO13485:2016 and MDR requirements.

  • Travel: 30% domestic travel annually, 5% international travel

Qualifications:

  • Bachelor's degree (B.A.) from four-year college and 3 years of quality engineering experience; or equivalent combination of education (Master's) and experience.

  • Experience performing audits needed; supplier quality auditing experience is highly desirable

  • Possess a good working knowledge of regulatory expectations and industry practices including industry standards QSR, 1013485, MDI, CMDR, JPAL.

  • Excellent organizational; problem solving; decision-making; communication (oral and written); and influencing skills.

Benefits:

Natus offers competitive salaries, comprehensive benefit package that starts on your 1st day, 401k match, an employee stock purchase plan, 9 paid holidays, generous paid time off plan (4 weeks to start) and tuition reimbursement up to $5,000 annually.

EEO Statement:

Natus Medical is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status.

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Quality Engineer - Supplier Quality

Natus Medical Incorporated