Quality Engineer

Melbourne, Australia  ·       Full time

Location: Melbourne, Australia

Time type: Full time

Job requisition id: JR-9870

Join us today and make a difference in people’s lives!

Job Purpose （12 month contrator）

Working closely with the Manufacturing Department, the Quality Engineering (QE) Specialist is primarily responsible for assisting in the execution and maintenance of projects that directly affect the day to day running of manufacturing. This includes providing guidance to both the manufacturing team and the development team on relevant standards and regulations.

Projects include the quality of starting materials and final product control and disposition.

• He/she will support the Quality Engineering and Regulatory Affairs Manager in the maintenance of the Quality Management System assisting in the analysis and trending of process data, evaluating nonconformities, driving investigations, and coordinating with other functions and stakeholders to make recommendation for product disposition and assist in coordinating the execution of the corrective and preventive action plans, driving continuous Improvement.
• He/she will be involved in internal and external Quality Audits to certify the compliance of the site Quality Management system and support the qualification and validation activities of the cleanroom.

Essential Job Functions

• Performs and coordinates routine incoming materials inspections and notify suppliers in case of components not meeting specifications
• Ensure proper in process controls are executed according to approved procedures
• Support the Quality Engineering and RA Manager during external audits in ensuring department preparedness and providing both information and requested support documentation
• Assist with transport study and shelf-life study projects
• Assist in the execution of process and equipment validations writing validation protocols and reports.
• Facilitate process and equipment risk assessments
• Make recommendation for decisions on nonconforming products identified in production
• Evaluate the risk posed by Nonconformances on products already distributed by performing risk assessments to determine if stop shipment and/or recalls are required
• Cooperate in the preparation of product quality control plans
• Coordinate investigations of the cause of V&V failures
• Support the Quality Engineering and RA Manager in collecting the process data and in monitoring the Key Performance Indicators (KPIs) for processes under her/his responsibility
• Support the implementation of CAPA plans.
• Ensure compliance with all Standard Operating Procedures (SOPs), ensure that SOPs are accurate, up-to-date and comply with regulatory requirements

Minimum requirements and qualifications

• Tertiary engineering degree in biomedical, science or related field
• Experience in medical devices or in pharmaceutical industry.  As a minimum experience within a highly regulated industry.
• Effective team player able to influence at all levels and across the business
• Proficient Engineering computer skills & Microsoft Office Suite
• High level of attention to detail
• Strong organisational skills
• Excellent written & verbal communication skills
• Accuracy Oriented

Values

• Patients First: Our Shared Purpose is to improve the lives of patients.
• Meaningful Innovation: We develop novel products and therapies to address multiple disease states.
• Act with Agility: We challenge ourselves to continuously improve and act nimbly.
• Commitment to Quality and Integrity: We dedicate ourselves to high quality and integrity in everything we do.
• Collaborative Culture: We value diversity of thought and our collective strength as a team.

Our commitment to Diversity & Inclusion:

LivaNova values equality and celebrates diversity. We are committed to ensuring that our recruitment process is fair, transparent and free from unlawful discrimination.

Our selection process is driven by the key demands/requirements for the role rather than bias or discrimination on the basis of a candidate’s sex, gender identity, age, marital status, veteran status, non-job-related disability/handicap or medical condition, family status, sexual orientation, religion, color, ethnicity, race or any other legally protected classification.

Background Checks at LivaNova:

Upon successful completion of the hiring process an offer may be extended. Please note, LivaNova reserves the right to conduct background investigations and/or reference checks on all its potential employees, where permitted by local legislation. This offer therefore, is contingent upon a clearance of such a background investigation and/or reference check, and can be rescinded, where permitted by local legislation, based upon data received in the background check and/or refusal to cooperate with or any attempt to affect the results of this check.

Notice to third party agencies:

Please note that we do not accept unsolicited resumes from recruiters or employment agencies. In the absence of a signed Recruitment Services Agreement, we will not consider, or agree to, payment of any referral compensation or recruiter fee. In the event that a recruiter or agency submits a resume or candidate without a previously signed agreement, we explicitly reserve the right to pursue and hire those candidate(s) without any financial obligation to the recruiter or agency.

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