Senior Quality Specialist

Description

At Smith+Nephew we design and manufacture technology that takes the limits off living.

What will you be doing?

Reporting to the Director - RA and Commercial Quality, ANZ, your role is to support all Business Units and Functions across Australia and New Zealand. As the Senior Quality Specialist, you provide high level strategic feedback and display strong leadership skills to engage peers & BU leaders. You are responsible for leading various quality system elements and driving QMS improvements. You drive improvement projects, act as Quality Champion across all ANZ sites, mentor others and are responsible for ensuring the QMS's proper function and compliance underneath the oversight of QMS management. You support the supply and distribution of our products consistent with our quality and compliance requirements and our customers’ expectations. You collaborate closely with Global and Regional Functions.

What will you need to be successful?

• Drive compliance of QMS processes Including but not limited to CAPA, NCs, Internal and External audit programs, Complaints and SCARs, Quality Management review, Change control, Document control, Training, Inductions and Onboarding, etc.
• Act as peer advisor and train elements of the QMS.
• Provide support to all RAQA team members and partners as needed.  Super User and Administrator of Smartsolve and handle any e-QMS initiatives, working with regional and global teams.
• Generate QMS KPI/metrics proactively identifying areas of concern, using process improvement techniques to drive improvements within the QMS by managing projects at the site levels.
• Maintain and Improve the Quality Management System. Complete the creation, implementation, updating, and training of quality management system procedures and associated workflows and interacting, engaging and supporting cross functional customers on all applicable SN platforms.
• Audit activities (Internal, External, Supplier) including follow up activities and Regulatory and Notified Bodies Inspection Readiness. Ensure compliance to cGDP, ISO 9001, ISO 13485 and any other applicable quality standards or regulations.
• Work with the Third-Party Logistics partners and support the SN Quality initiatives, in partnership with the QA colleagues. Attend and represent Commercial Quality at Quality meetings and Business Review Meetings.
• Execute ASC (Australian Service Centre) QMS activities, supporting the Service Centre QMS initiatives.
• Partner with Operations/Supply Chain and Logistics; and BUs to ensure QMS compliance and business outcomes.
• Partner with Supplier Quality Management and Supplier Auditing.
• Partner with Tenders and Contract - Ensure meeting QMS requirements with Tenders and Contracts
• Oversee, support, and implement where needed HINs -Hold Notifications, Field Actions, Supplier Quality, Complaints (Reporting, Investigations, Letter writing and Decision Trees) and Product returns process. Support post market reporting requirements reporting to regulators and meeting the reporting requirements.

Requirements:

• Education: Technical/Business Undergraduate and/or Post Graduate B.S. in Science, Health Sciences, Engineering, Medical or related scientific field
• Experience:  8 years S+N experience OR 8-10 years relevant medical devices experience 
• Quality associated with Medical Devices and Biologics, preferably across devices, medicines/pharmaceuticals experience will be an advantage, preferably the orthopaedics Industry /Healthcare
• Demonstrated knowledge of the Therapeutic Goods Administration and the TGA Act as well as Medsafe and the NZ Therapeutic Products Framework

To apply, please ensure that you include a cover letter addressing it to Talent Acquisition Lead ANZ. Due to a high volume of applications, please note that only shortlisted candidates will be contacted.

You. Unlimited.

We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve.  

• Inclusion, Diversity and Equity- Committed to Welcoming, Celebrating and Thriving on Diversity, Learn more about Employee Inclusion Groups on our website (https://www.smith-nephew.com/ ). 
• Work/Life Balance: Flexible Personal/Vacation Time Off, Paid Holidays, Flex Holidays, Paid Community Service Day
• Flexibility: Hybrid Work Model (For most professional roles)
• Training: Hands-On, Team-Customized, Mentorship

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