Post Market Quality Analyst

Description:

At Natus, our team is united by a common goal - to enhance the standard of patient care worldwide. We bring together individuals from diverse backgrounds who collaborate to enhance the quality of life for patients globally. Our organization takes a holistic approach, focusing on providing top-notch equipment, support, and education. We are dedicated to excellence, ensuring that our products and team members meet the highest standards.

Natus is renowned for being a leading provider of solutions for screening, diagnosing, and treating disorders that impact the brain, neural pathways, and sensory nervous systems. We are currently seeking new talent to join our dynamic team. If you are passionate about making a difference in people's lives, you could be the perfect addition to our team. Join us at Natus and be a part of our mission to improve patient care worldwide.

The Job: The Quality Assurance team is seeking a Post Market Quality Analyst responsible for evaluating communications related to Adverse Events, ensuring timely completion of complaint records, and reporting identified AEs to relevant regulatory authorities within specified timelines. This role also involves the reporting and coordination of both internal and external Field Corrective Actions, ensuring all actions are executed within the required timeframes.

Duties and Responsibilities in this job:

· Evaluate and document incoming complaints from various channels.

· Ensure accurate complaint records are maintained in the PLM system.

· Conduct follow-ups to gather additional information as needed.

· Collaborate with Engineering for technical investigation reports.

· Maintain audit-ready documentation of investigation results.

· Liaise with cross-functional teams during complaint processing.

· Accurately categorize complaints for trend analysis.

· Review risk management files and assign relevant hazards.

· Ensure all information is available to determine complaint reportability.

· Coordinate Adverse Event Reporting and Field Corrective Actions.

· Assist with Product Correction and Removal processes.

· Organize meetings to track task completion.

· Report metrics for Management Review and process improvements.

· Stay updated on Quality System procedures and ensure compliance.

· Actively participate in Quality System-related projects.

· Support QMS certification for MDSAP, ISO13485:2016, and MDR.

· Provide Quality System support during Regulatory Audits.

· Offer periodic training on Quality Systems processes.

Our ideal candidate will have the following qualifications and skills:

· A third level qualification in naturals sciences or related field.

· Minimum of 2 years' experience in a similar role within Medical Device industry; we will consider a combination of education and experience.

· Good technical capabilities, communication skills, teamwork abilities and initiative.

· Proven ability to work well both as part of a team but also able to work on own with minimum supervision.

· Microsoft Office systems required.

· Proven ability to review and analyse Quality Critical technical documents.

· Knowledge of statistical packages, (e.g Minitab) preferred but not required.

We offer

• The role is a work-from-home remote position.
• Minimal travelling: less than 5%.
• Collaborative and international environment with different cultures.
• English company language.

EEO Statement

Natus Sensory 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.