Senior Quality Specialist

Cyclomedica; Canterbury-Bankstown; On-site; AUD 110,000 - 150,000; Full time

Benefits offered by this job

Vaccination program

Employee Assistance Program

Discounted gym membership

Job summary

Cyclomedica, a leader in nuclear imaging solutions, invites a Senior Quality Specialist to join the Kingsgrove team. The 12-month temporary contract offers on-site work with potential extension and flexibility for full- or part-time hours.

Reporting to the Head of Quality, you will review engineering and operational deliverables, drive continuous improvement, support supplier quality, audits, non-conformance investigations, and change control across the Quality Management System in compliance

Qualifications

• University degree in Science, Engineering or equivalent.
• Minimum 5 years' experience in a Quality Engineering role.
• 5-10 years’ experience in a similar role within a medical device / GMP environment.
• High level of verbal and written communication and numeracy skills.
• Thorough knowledge of standards and governing bodies.
• Excellent problem-solving skills.
• Proficient attention to detail, excellent written and verbal communication skills.
• Ability to work as part of a team.

Responsibilities

• Promote a strong quality and continuous improvement culture across the organisation.
• Collaborate with Operations and Engineering to resolve quality issues and drive continuous process improvement.
• Support Supplier Quality activities.
• Auditing experience desirable.
• Support internal and external audits as required.
• Change control for product and process changes, ensuring quality requirements are addressed.
• Review and approval of medical device engineering and operational work deliverables.
• Act as the quality representative for project meetings, change controls, material review meetings, NC meetings etc.
• Candidates should have strong practical experience in Medical Device Design (ISO 13485) and Risk Management (ISO14971).
• Experience in NC-CAPA, Deviations, Root Cause Analysis, Risk Assessments, Complaints.
• Strong attention to detail and ability to manage multiple quality activities effectively.
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams.
• Other tasks as required to ensure a smooth-running Quality Management System adhering to regulations.

Skills

Quality engineering

Medical device GMP

ISO 13485

ISO14971 risk management

Verbal and written communication

Problem solving

Detail-oriented

Teamwork

Education

University degree in Science/Engineering

Job description

We are Cyclomedica - bringing light into nuclear imaging since 1986. We have paved the way with nuclear medicine solutions in Australia and around the globe. From innovation, development to clinical practice applications - we are the world leaders in functional lung ventilation imaging with our proprietary technology: Technegas®.

Created and manufactured in Australia our flagship product Technegas® has revolutionised diagnostic lung imaging and today transform the lives of millions of patients in more than 66 countries around the world.

The site is FDA licenced for drug and device manufacturing and holds a TGA cGMP certificate as well as ISO:13485 certificate for the manufacture of its own CE marked Class IIb /IIa medical devices.

About the role

We are seeking a talented Senior Quality Specialist to join our professional and committed team in Kingsgrove.

• 12-month temporary contract, with the possibility of extension
• Open to Full-time or part-time hours.
• On-site in Kingsgrove office.

Reporting to the Head of Quality, this role will focus on reviewing and approving engineering and operational project deliverables to ensure quality requirements are met. The position will also support a broad range of quality activities, including change control, supplier quality, audits, non-conformance investigations and continuous improvement across Cyclomedica’s Quality Management System.

Key Responsibilities

• Promote a strong quality and continuous improvement culture across the organisation
• Collaborate with Operations and Engineering to resolve quality issues and drive continuous process improvement
• Support Supplier Quality activities
• Previous auditing experience is highly desirable
• Support internal and external audits as required
• Support change control for product and process changes, ensuring quality requirements are addressed
• Review and approval of medical device engineering and operational work deliverables
• Act as the quality representative for project meetings, change controls, material review meetings, NC meetings etc
• Candidates should have strong practical experience in Medical Device Design (ISO 13485) and Risk Management (ISO14971)
• Experience in NC-CAPA, Deviations, Root Cause Analysis, Risk Assessments, Complaints
• Strong attention to detail and ability to manage multiple quality activities effectively
• Excellent communication and interpersonal skills, with the ability to work effectively with cross-functional teams
• Other tasks as required to ensure a smooth-running Quality Management System adhering to regulations

Skills and Experience

• University degree in Science, Engineering or equivalent
• Minimum 5 years' experience in a Quality Engineering role
• 5-10 years’ experience in a similar role within a medical device / GMP environment
• High level of verbal and written communication and numeracy skills
• Thorough knowledge of standards and governing bodies
• Excellent problem-solving skills
• Proficient attention to detail, excellent written and verbal communication skills
• Ability to work as part of a team

Why Join Our Team?

• Rare opportunity to join a company that manufactures both drug and medical device with exposure to FDA, TGA and European Notified Bodies.
• Competitive and attractive salary package
• Professional development opportunities
• Health and wellness benefits such as Vaccination Program, Employee Assistance Program and discounted gym membership
• Be part of an inspired and talented leadership team
• Company culture that values respect, collaboration, innovation and ethics

You will be joining an organisation that embraces diversity & inclusion.

We are committed to providing products, services and solutions that improve clinical outcomes everyday. If you feel the same - we would welcome your application!