Quality System Specialist - Pinkenba, Australia - ImpediMed

Description

ImpediMed is looking for a
Quality System Specialist to join our team If you have a passion for engaging in customer-focused quality systems transformations, as well as a driven dedication to assuring compliance to regulatory requirements, then this role is for you This position plays a vital role in ensuring all employees are fully trained on ImpediMed's quality system requirements and manages the corrective and preventative action systems ensuring proper execution. This is a hybrid position based out of our Brisbane, AU office.


A day in your life as a Quality System Specialist at ImpediMed may include:

• Support the Director of Quality in planning and driving completion of all project milestones.
• Instruct staff on ImpediMed's quality system.
• Manage and maintain our corrective and preventive action processes, as per our quality system, and look for continuous improvements and enhancements.
• Receiving, reviewing and analyzing customer feedback and complaints to identify trends
• Take lead on coordinating with Sales, Engineering, Contract Manufacturer, and Customer Service to resolve customer complaints and concerns as they relate to quality issues.
• Provide backup support to Customer Experience/ Technical Support team.
• Support new product development teams and sustaining manufacturing/operation teams to ensure successful development and transition from design to production, including risk management.
• Perform internal audits of the company's QMS.
• Lead onsite and/or virtual supplier audits for EMEA.
• Initiate and monitor supplier performance through Nonconformance Material Reports (NCMR) and assist in defect identification and troubleshooting.
• Drive supplier quality development by evaluating supplier processes (supplier surveys) and/or product tooling validations.

To be an amazing Quality System Specialist at ImpediMed, you will have:

• Bachelor's degree in engineering, preferably Bioengineering, or equivalent combination of education and experience and 3-5 years of experience in a quality position or related experience in manufacturing.
• Demonstrated experience in a Class 2a Medical Device industry or closely related industry strongly preferred.
• A minimum of two (2) years with Quality Supply Management or related experience preferred.
• American Society for Quality Certification (ASQ) or equivalent as a Quality Auditor or Quality Engineer highly recommended.

What We Offer:

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Life at ImpediMed

• It is fast, it is fun, it is evolving, it is growing, and it is filled with smart, passionate, diverse, friendly people who want to make a difference in healthcare.

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Total Rewards:

• At ImpediMed, we are strongly committed to our employeestheir wellbeing, development, rewards, and recognition opportunities. One way we demonstrate this commitment is by offering a competitive compensation package. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.

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Benefits - Benefits will vary depending on geographical location or by country.


About ImpediMed

Founded and headquartered in Brisbane, Australia with US and European operations, ImpediMed is a medical technology company that uses bioimpedance spectroscopy (BIS) technology to generate powerful data to maximise patient health.

ImpediMed produces the SOZO Digital Health Platform, which is FDA-cleared, CE-marked, and ARTG-listed for multiple indications, including lymphoedema, heart failure, and protein calorie malnutrition and sold in select markets globally.

In March 2023, the NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines) for Survivorship were updated and reference bioimpedance spectroscopy as the recommended objective tool to screen at-risk cancer patients for early signs of lymphoedema.

With the SOZO Digital Health Platform and L-Dex, ImpediMed is the only company to offer FDA-cleared technology that uses bioimpedance spectroscopy for the clinical assessment of lymphoedema.

The connected digital health platform and large, attractive cancer-related lymphoedema market present an opportunity for continued strong growth through ImpediMed's SaaS subscription-based business.

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