Quality professionals with GMP and documentation expertise will find this role in a regulated medical device manufacturing environment in Western Australia.
Derived from job-description analysis by Serendipath's career intelligence engine.
Original posting from Anteris Technologies via Greenhouse
Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.
Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve.
The Quality Associate supports the effective operation of Quality Assurance and Quality Control activities at the Malaga site, contributing to the manufacture and release of safe, compliant, and high-quality medical devices.
This individual will perform defined Quality Control activities associated with final product inspection, bioburden reduction, and external sample testing, alongside Quality Assurance activities including batch record review, document control, controlled document and label issuance, and review of GMP records. The Quality Associate also supports the ongoing effectiveness of the Quality Management System through quality investigations, internal auditing and continuous improvement activities.
Working collaboratively with Manufacturing and the broader Quality team, the role ensures Quality activities are completed accurately, efficiently, and in accordance with approved procedures, GMP, and applicable Quality Management System requirements.
Main Responsibilities:
- Perform visual inspection of final product in accordance with approved procedures, specifications and acceptance criteria.
- Perform the bioburden reduction process for final product in accordance with approved procedures, ensuring appropriate handling, identification, traceability and documentation.
- Coordinate preparation and shipment of samples to approved external laboratories for required testing, ensuring appropriate sample identification, documentation, traceability and follow-up.
- Review completed batch manufacturing records for accuracy, completeness, compliance with approved procedures and resolution of identified discrepancies prior to progression through the batch release process.
- Generate, print, issue and control approved batch manufacturing records and product labels for in-process and final product manufacturing activities.
- Support document control activities including issuance, distribution, maintenance, archival and control of Quality Management System documents and records.
- Review GMP records for completeness, accuracy and compliance with applicable procedures and good documentation practices, identifying and escalating discrepancies as required.
- Identify and appropriately document quality issues, non-conformances and deviations and support their investigation and resolution in accordance with the Quality Management System.
- Participate in CAPA investigations, including gathering and evaluating information, supporting root-cause analysis, identifying appropriate corrective and preventive actions and documenting investigation outcomes.
- Train and qualify as an internal auditor and conduct internal audits in accordance with the approved audit program, documenting observations and supporting follow-up of identified actions.
- Support internal and external audits by preparing documentation, providing records and information and assisting with audit activities as required.
- Work collaboratively with Quality, Manufacturing and other functions to resolve quality and documentation issues and support site operational requirements.
- Identify and contribute to opportunities to improve Quality processes, documentation, compliance and efficiency.
Skills, Knowledge, Experience & Qualifications
- Relevant qualification in Science, Laboratory Techniques, Quality, Medical Device Manufacturing or a related discipline, and/or relevant experience within a medical device, pharmaceutical or other regulated manufacturing environment.
- Working knowledge of GMP, good documentation practices and Quality Management System requirements, with an understanding of the importance of traceability, document control and accurate quality records.
- Demonstrated ability to accurately perform and document Quality Control inspection and processing activities and review manufacturing and GMP records against approved requirements.
- Strong attention to detail, analytical and problem-solving skills, with the ability to identify discrepancies, gather and evaluate information and contribute to quality investigations and root cause analysis.
- Strong organisational and document-management skills, with the ability to manage multiple Quality activities and maintain accurate controlled records.
- Sound communication and interpersonal skills, with the ability to communicate quality concerns constructively, participate in audits and work effectively across Quality, Manufacturing and other functions.
- Proficient computer skills and the ability to work effectively both independently and as part of a multidisciplinary team.
Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.