Senior QA Associate

We are one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Our products and services are available in over 100 countries around the world. We aim to help people lead more active and more satisfying lives.We are looking for an enthusiastic positive senior QA Associate who is eager to learn and contribute. You will work as part of QA Team to assist all tasks and functions of Regulatory Affairs / New Product Development / Formulating / QA systems.About the role:Lead internal and external audit activities to ensure trials are conducted in accordance with the protocols, Industry Guidelines and applicable StandardsLiaise with the team on technical issues including formulations, quality, stabilitySupport and encourage Continuous Improvement initiatives across Training and Best practice sharingProvide mentoring and assistance to junior members of Quality teamMonitoring and reporting of quality activity ensuring management is informed in a timely manner of changes/trends that could affect SSPs quality systemParticipate in developing SOPs and training courses as requiredSkills and Experience Required:5+ years’ experience in Medical Device Quality Systems, including operational experience Knowledge of validation of equipment and processesExperience in Good Document Practice (GDP), Document management and controlExperience in implementing and maintaining quality systems Good communication skills and eager to learnWork as a Team with Can-Do attitude and creative thinkingPreferable experience with ISO 13485, FDA, GMP (PIC/s), CMDCAS, MDSAPLead audit certification in ISO13485/9001 Quality SystemStrong technical writing skillsAbility to work to strict deadlinesSelf-motivated, committed & able to take initiative to deliver resultsAbility to demonstrate strong customer focus and attention to detailAble to travel as required by the businessPlease feel free to email me directly on kstefanovic@frontlinehealth.com.au Australia - NSW Sydney

Senior QA Associate

  • Market leading medical devices company
  • Great Career Progression opportunity
  • Outstanding training and support

We are one of the world's leading medical technology companies and is dedicated to helping healthcare professionals perform their jobs more efficiently while enhancing patient care. Our products and services are available in over 100 countries around the world. We aim to help people lead more active and more satisfying lives.

We are looking for an enthusiastic positive senior QA Associate who is eager to learn and contribute.
You will work as part of QA Team to assist all tasks and functions of Regulatory Affairs / New Product Development / Formulating / QA systems.

About the role:
Lead internal and external audit activities to ensure trials are conducted in accordance with the protocols, Industry Guidelines and applicable Standards

Liaise with the team on technical issues including formulations, quality, stability

Support and encourage Continuous Improvement initiatives across Training and Best practice sharing

Provide mentoring and assistance to junior members of Quality team

Monitoring and reporting of quality activity ensuring management is informed in a timely manner of changes/trends that could affect SSPs quality system

Participate in developing SOPs and training courses as required


Skills and Experience Required:
5+ years’ experience in Medical Device Quality Systems, including operational experience
Knowledge of validation of equipment and processes
Experience in Good Document Practice (GDP), Document management and control
Experience in implementing and maintaining quality systems
Good communication skills and eager to learn
Work as a Team with Can-Do attitude and creative thinking
Preferable experience with ISO 13485, FDA, GMP (PIC/s), CMDCAS, MDSAP

Lead audit certification in ISO13485/9001 Quality System

Strong technical writing skills

Ability to work to strict deadlines

Self-motivated, committed & able to take initiative to deliver results

Ability to demonstrate strong customer focus and attention to detail

Able to travel as required by the business

Please feel free to email me directly on kstefanovic@frontlinehealth.com.au


To apply online, please click on the apply button and attach your CV and Cover Letter preferably in Word format

Alternatively, for a confidential discussion, please contact Katie Stefanovic on +61 (2) 8249 4019 or 0401 908 007, quoting Ref No. 145906. Please continue to check our website for other positions available.

www.frontlinehealth.com.au