Senior Quality Specialist

Company description:

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Job description:

Senior Quality Specialist

Benefits & Highlights:

• Competitive base salary + annual bonus
• Annual cash allowances for health insurance & wellness
• Excellent leadership, mentoring support with ongoing training & development
• Future career progression opportunities as a result of exceptional double digit YoY business growth
• Excellent ongoing training & development
• Great rewards and recognition programs

Reporting to our QA Manager and working with an experienced Quality team, this role will maintain compliance to corporate quality requirements affecting company operations and products.

This is a hybrid work opportunity e.g.: typically working 3 days per week from our office or operations facility, plus working from home. A main component of the role will be working in Post-Market.

About the Role

You will focus on supporting our Operations teams e.g.: Warehousing (3PL), Loan Kits, Service & Repair, and Customer Services.

Example responsibilities include: documentation control, corrective action preventive action (CAPA), post-market surveillance and QMS auditing.

Furthermore, you will:

• Maintain a document management system for ANZ ensuring accuracy and completeness as well as document security
• Performs quality related activities such as complaint management, field actions, adverse event reporting in ANZ, loaner set inspection
• Quality liaison with Third Party suppliers (Warehouse) and supports Quality Activities within the Warehouse
• Lead supplier and internal audits ensuring effectiveness of quality management system
• Initiate internal corrective actions necessary to ensure overall quality compliance
• Lead and drives quality implementation projects
• Follow up on effectiveness of CAPA
• Perform analysis of internal quality data and prepare management reports on quality metrics

About the Requirements

• You are an experienced, senior, quality assurance professional.

  You have good interpersonal skills, work well in a fast-paced environment, and can manage multiple projects concurrently.

  Any experience with the following would also be beneficial and highly considered:

• Experience within operations, logistics (especially reverse logistics), manufacturing or even orthopaedic medical devices.
• Knowledge of TGA, MEDSAFE regulations,
• Experience with ISO 13485:2016 standard,
• Relevant tertiary qualifications (engineering or life sciences are ideal),
• SAP experience.

About Arthrex

Arthrex is a global medical device company and leader in new product development and medical education in Orthopaedics. With a corporate mission of Helping Surgeons Treat Their Patients Better™, Arthrex has pioneered the field of arthroscopy and develops more than 1,000 innovative products and procedures each year. We are a privately held company with a family business culture committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

The successful applicant MUST have rights to work in AU, a valid Driver Licence