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Quality Assurance Specialist

Pettit Pharma & Device Search
$100K + super

Job Description

This organisation prides themselves on being an extremely flexible workplace, with a focus on outcomes, rather than location or hours. Family culture.

  • This Australian early-stage medtech start-up, established 4 years ago, is working to improve women’s health, leveraging AI-enabled technology to reinvent care for women and babies.
  • They utilise cutting edge technologies and create completely novel technologies to generate solutions that seek to treat complications that have been previously undiagnosable.
  • This organisation prides themselves on being an extremely flexible workplace, with a focus on outcomes, rather than location or hours. The company offers a uniquely supportive environment for learning, as well as opportunities for growth for high-performers.
  • This role will provide you a unique opportunity to work with a passionate team and make a difference, using your skills to directly improve outcomes for mothers, babies and clinicians.
  • You will have the opportunity to gain hands-on experience and develop your knowledge, while creating ground breaking solutions.
  • They are seeking a Quality Assurance Specialist who is passionate, curious and wants to use their skills to make a difference in the world.
  • The primary function of this QA role, will be contributing to the development, implementation and maintenance of the quality assurance system and related policies and procedures to ensure compliance with relevant GCP and GMP requirements.
  • The position will assist in the development of the Quality Management System (QMS) and work closely with the design and manufacturing team to coordinate the preparation, review and issue of SOPs to support quality systems.
  • You will implement and conduct manufacturing quality processes and prepare and review test plans, protocols and reports for adequacy ensuring product meets all specifications.
  • You will analyse data, create reports and communicate results to the broader team and assist the clinical team in the preparation of clinical documentation for clinical trials and develop inspection and testing methods for incoming and outgoing material ensuring they meet all specifications.
  • You will actively participate as a compliance and quality representative on projects and be involved in the Supplier & Internal Quality Audits program as an auditor and support regulatory audits and customer audits as necessary.
  • Maintaining an up-to-date knowledge of the latest requirements relating to GCP and regulatory requirements in Australia and overseas is part of this role as is performing investigations and root cause analysis and developing and implementing corrective and preventative actions in collaboration with other departments.
  • Bachelor degree in the appropriate discipline (eg. Bachelor of Science, Bachelor of Engineering), or equivalent experience.
  • Minimum four years’ experience in a Quality Engineer or Quality Assurance position in the medical devices or pharmaceutical industries or GCP environment.
  • Knowledge of ISO 13485 and, preferably exposure to 21 CFR Part 820 and its implementation.
  • Proficient skills in Microsoft platforms such as Word and Excel.
  • Strong quality-focus and a proactive approach to quality system improvement and management through continuous improvement methodologies.
  • It is a requirement of employment in this role that you are fully vaccinated against covid-19.
Interested? Please 'apply now' quoting reference number 3271 or call Elizabeth Pettit, on 02.8310.9129. Please note, your details/resume will not be sent anywhere without a formal interview and, if successful, your subsequent prior permission. Personal information provided will be used for recruitment purposes only and be treated in the strictest confidence. Only shortlisted candidates will be contacted.