facebook

Job details

Location
New South Wales
Salary
Competitive Salary package
Job Type
Full Time
Ref
BH-41618
Contact
Tamara El Husseini
Contact email
Email Tamara
Contact phone
+61 2 8877 8775
Posted
25 days ago

Job details

Location
New South Wales
Salary
Competitive Salary package
Job Type
Full Time
Ref
BH-41618
Contact
Tamara El Husseini
Contact email
Email Tamara
Contact phone
+61 2 8877 8775
Posted
25 days ago

Benefits
• Opportunity to join a reputable medical device and pharmaceutical manufacturer with exposure to FDA, TGA and European Notified Bodies.
• Collaborative, respectful, and innovative company environment.
• Competitive Salary Package.
• Career progression opportunities.
• Onsite Parking.

About the company
With over 30 years’ experience in research and design, this medical device company brings an innovative and niche product to the healthcare industry. The Sydney-based device company is 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 have obtained new market share and enhanced products.

About the opportunity
As the Head of Quality, you will be required to oversee the Quality and Regulatory department onsite daily. Your responsibilities will include managing quality systems, ensuring audit-readiness, maintaining accurate records and reporting, and promptly closing out any CAPA or audit findings. To excel in this role, you must possess strong leadership experience, comprehensive knowledge of medical device ISO regulations and pharmaceutical regulatory guidelines, as well as excellent planning, influencing, and interpersonal skills.

Duties
• Maintaining and updating quality system requirements in compliance with regulatory standards.
• Reporting data metrics on the quality system to executive management.
• Ensuring all necessary testing is conducted in a timely manner.
• Oversight of regulatory compliance, including Internal and External Audits.
• Implementing a Risk Management Program and supervising customer complaints.
• Approving procedures and documents related to Preventive Maintenance, Calibration, Validation, and Qualification.
• Maintaining out-of-specification, deviation, out-of-trend, change control, nonconformance, and stability programs.


**Please note, the ideal candidate is locally available and has unrestricted working rights in Australia.

Skills and Experience
• Tertiary qualification in a Science, Engineering, or related field
• Minimum 10 years of Quality Assurance experience in a GMP-certified medical device or pharmaceutical setting, ideally encompassing both areas.
• Minimum 7 years of QA management experience.
• Experience in FDA, TGA, and ISO13485 auditing is a must.
• Strong written and verbal communication skills.
• Great organizational, influencing, and problem-solving skills.
• Demonstrated capacity to effectively lead, direct, and mentor a team.

Culture
This company has a collaborative team environment valuing integrity, innovation, and quality whilst manufacturing and developing innovative technologies.

How to Apply
Click apply or email Tamara El Husseini, Recruitment Consultant on telhusseini@hpgconnect.com for a confidential discussion.

Similar jobs

28 days ago

Quality Assurance

Business Quality Lead

  • North Sydney
  • Competitive Salary Package

Benefits• Free Onsite Parking• Hybrid role 3 days from home + 2 pre-set days onsite.• Team building and bonding activities.• Staff discounts on products.• Health benefits.About the companyOur client is a globally recognised multinational company specialising in consumer products. They have a strong presence in the industry and are renowned for th...

20 days ago

Engineering

Senior Quality Associate

  • Melbourne
  • $67 - $68.72 per hour

About the companyOur client is an Australian multinational specialty biotechnology company that research, develops, manufactures, and markets products to care for and avoid serious human medical conditions.About the opportunityOur client is seeking a R&D Senior Quality Associate to join their team in Melbourne, reporting into the R&D Quality Comp...

29 days ago

Medical Affairs

Medical Science Liaison Lead

  • Sydney
  • Attractive Salary Package

About the companyThis medium speciality global biopharmaceutical company is renowned for its expertise and is dedicated to helping people build healthy families and live better lives.About the opportunityThis field based role will also be crucial in leading and managing the field-based MSL team. You will coordinate, supervise, and support MSL activit...

21 days ago

Human Resources

Capability Development Partner

  • Rhodes
  • $95000 - $100000 per annum, Benefits: Super and Salary Packaging

Benefits:$95,000 - $100,000 + Super + Salary PackagingSupportive work-life balance - working 3 days from homeEngaging and collaborative work environmentAbout the company:A dynamic and forward-thinking non for profit organisation with a national presence. Specialising in community services, are r...

27 days ago

Quality Assurance

Post-Market Manager

  • North Sydney
  • Competitive Salary Package

Benefits• Free Onsite Parking.• Discounts on a wide range of products.• Gym membership.• Rest, energize, and connect days. About the companyOur client is a leading Medical Device organisation with a strong presence in Australia, New Zealand, and Asia. This organization places high importance on quality and dedicated support, the company has built a s...

17 days ago

Sales

Account Manager

  • Sydney
  • $105000 - $115000 per annum, Benefits: Car, super & bonus

The Benefits:Newly created roleUpcoming novel product launchMarket leading portfolioGlobal R&D Pharmaceutical companyExciting pipelineHighly engaged & excited customersDisrupt the landscape of an under recognised diseaseVaried customer base

19 days ago

Allied Health

Dental Territory Manager

  • Parramatta
  • $140000 - $160000 per annum, Benefits: $150k- $170k + Super + Bonus

About the Role:  This Territory Manager role will oversee the operations of between 6- 12 dental practices. With over 150 staff across these sites, this role requires someone that can act as a leader and a strategic partner. Focus will be on improving SOPs, workflows and training to increase revenue. Benefits for You:Career Progression:&...

5 days ago

Quality Assurance

Analyst - QC Sample Management

  • Dallas
  • $35.08 per hour

BenefitsBe part of a supportive and stable working environmentWorking within a global teamMust have unrestricted working rights in AustraliaAbout the companyWork within a large global Biotechnology company that boasts a good company culture that is always expanding.About the opportunity

18 days ago

Sales

Territory Manager

  • Perth
  • Base: $100-110k + Company Car + Super + Profit Sharing

About the CompanyOur client is a leading designer, manufacturer and marketer of healthcare products and systems for use in respiratory care, acute care, and the treatment of obstructive sleep apnoea. Their aim is to consistently develop innovations to improve patient care and developed world-wide distribution for these products.The OpportunitySeeking...

about 17 hours ago

Medical Affairs

MSL Manager

  • Melbourne
  • $160000 - $170000 per annum

BenefitsHighly competitive remuneration including base salary, bonus, car allowance and superannuation Ability to manage direct reports Market-leading Medical team dedicated to collaboration and innovationAbout the Company Globally recognized for their commitment to development and ingenuity, this mar...

22 days ago

Medical Affairs

Medical Science Liaison

  • Perth
  • Competitive

BenefitsNational Territory Development: Ability to develop and manage multiple territories across Cardiovascular.Lucrative Remuneration: Highly lucrative remuneration package, including bonus and car allowance.Strategic Support: Well-established national strategic Medical Science Liaison team, directly supported by several Medic...

about 2 months ago

Medical Affairs

Medical Science Liaison - MSL

  • Sydney
  • Great salary and benefits package

Benefits:Competitive salary and comprehensive benefits packageOpportunity to work with unique products Collaborative and supportive team environmentAbout the Company:Join a renowned healthcare company dedicated to serving the medical and scientific community, providing innovative solutions in ...