facebook

Job details

Location
New South Wales
Salary
Attractive Remuneration Package
Job Type
Full Time
Ref
37727
Contact
Madeleine Byrnes
Posted
4 days ago

Job details

Location
New South Wales
Salary
Attractive Remuneration Package
Job Type
Full Time
Ref
37727
Contact
Madeleine Byrnes
Posted
4 days ago

Benefits

Opportunity to lead a team as the Head of Quality operations at Cyclomedica, an Australian owned and rapidly growing medical device company. You will be exposed to a wide range of local and overseas regulations as the product is marketed in 60 countries worldwide and is on the cusp of entering the US market with their ground-breaking medical innovations. There will be an attractive salary package and flexible working arrangements.

About the company

With over 30 years' experience in research and design, Cyclomedica brings an innovative and niche radiopharmaceutical product to the healthcare industry. They are driven by enhancing and developing medical innovations for diagnostic imaging, specialising in lung health. This is an exciting time to join the organisation as they embark on obtaining new market share and enhancements of their products.

About the opportunity

Cyclomedica is an Australian company based in the South Sydney suburb of Kingsgrove, which is within 15km of the CBD. As Head of Quality operations the role will be predominantly based on-site with some flexibility to WFH. Your role will be to ensure the continued compliance with regulatory guidelines and standards in Australia and with overseas regulatory bodies. Maintenance of the QMS in line with ISO 13485, GMP, MDSAP, EUMDR requirements.

Duties

  • Identify, define, and implement CAPA projects
  • Oversee the maintenance of the QMS and report findings to relevant parties
  • Oversee the investigation and response to product defects and complaints
  • Lead supplier development, gap closure and remediation activities
  • Build rapport with suppliers by networking and operating as the Primary Quality Point of Contact to suppliers for both development and commercial products
  • Development of training programs and inspection plans
  • Maintain a state of inspection readiness
  • Build and maintain quality specifications and standards for products
  • Maintain and develop the Quality policies and procedures

Skills and Experience

  • Tertiary qualification in Science, Engineering, or relevant discipline
  • Extensive GMP experience within Medical Devices
  • Experience in a Quality management position with strong leadership qualities
  • Excellent knowledge of GMP, ISO 13485, GDP/GWP standards
  • Strong communication skills and ability to collaborate with key stakeholders and partners
  • High attention to detail with ability to problem solve

Culture

Collaborative team environment. Company values integrity, innovation and quality whilst manufacturing and developing innovative technologies.

How to Apply

Click apply or contact Joanna Murphy, Specialist Manager on 0288778718 for a confidential discussion.

Similar jobs

16 days ago

Quality Assurance

Quality Manager

  • New South Wales
  • Negotiable

About the companyA distinguished Australian medical device company that manufactures and distributes a vast range of medical and surgical products. They strive to offer innovative solutions to make a difference to patients lives. The company have a collaborative culture and pride themselves on their environmentally sustainable practices. About th...

9 days ago

Quality Assurance

Senior Quality Assurance Associate

  • Kingsgrove
  • Negotiable

BenefitsThe opportunity to be a Senior Quality Assurance Associate at Cyclopharm has become available. You will have the unique opportunity to gain experience within Quality Assurance at a company on the cusp of joining overseas markets with their ground-breaking medical innovations.About the companyWith over 30 years' exp...

16 days ago

Quality Assurance

Quality Manager

  • Sydney
  • Negotiable

About the companyA distinguished global pharmaceutical company with facilities worldwide. The company prides itself on compounding products of the highest quality by having a proactive approach to enhancing quality control. The company believes their best asset is their people and they are passionate about working collaboratively to make a difference to the lives of m...

30 days ago

Quality Assurance

Quality Control Associate

  • Northern Beaches
  • AU$70000 - AU$80000 per annum + super + salary packaging

About the company Small scale packaging facility of vitamins and minerals. The company is part of a larger not-for-profit organisation passionate about improving lives by creating career opportunities for people with disabilities. About the opportunity This is a 12-month contract role (with possible extension) for a Qua...

24 days ago

Quality Assurance

APS 6 Compliance Assessor

  • Canberra
  • Negotiable

BenefitsGain unique experience in technical and regulatory affairs working for the Medical Devices Authorisation Branch of the TGA. About the companyThe Medical Devices Authorisation Branch of the TGA evaluates medical devices, including in vitro diagnostic medical devices (IVDs), and monitors them throughout their lifecycle to en...

about 15 hours ago

Executive Roles

External Affairs Director

  • Melbourne
  • Market leading salary & benefits package

Founding member of ANZ Leadership TeamEstablish and lead Government / External Affairs for ANZDynamic and innovative healthcare organisationMarket leading remuneration and benefits package​Healthcare Professionals Group have partnered with this ground-breaking healthcare organisation t...

3 days ago

Quality Assurance

Regulatory Affairs Manager

  • New South Wales
  • Negotiable

About the companyA distinguished global pharmaceutical company specialising in generic medicines with facilities worldwide. The company prides itself on their strong R&D focus that has resulted in an exciting product pipeline. The company also has expertise in all aspects of the drug development process from product formulation to the manufacturing of the product....