Quality Manager - Electrical Manufacturing & Qms Leader

Add Staff, Inc; Sydney; On-site; AUD 120,000 - 190,000; Full time

Job summary

Grifols is seeking a Quality Manager to ensure compliant distribution of medical devices and IVD products, maintain the affiliate's Quality Management System, and act as the key local contact for quality and regulatory matters reporting to Corporate Quality in Spain.

You will implement the Quality System, manage distribution licenses, coordinate recalls and CAPAs, and collaborate with Regulatory, General Manager, and Corporate Quality teams in a global setting.

Qualifications

• 3+ years of experience in Quality or Regulatory roles within a multinational environment.
• Experience with medical devices or IVDs preferred.
• Experience implementing or maintaining a Quality System (ISO 9001 desirable).

Responsibilities

• Implement, maintain, and improve the affiliate's Quality System in line with corporate policies and Korean regulatory requirements.
• Manage product distribution activities (storage, shipping, transport) and ensure licenses remain valid.
• Act as in-country quality contact for customers, distributors, and authorities; coordinate complaint management with Grifols sites.
• Qualify suppliers; perform periodic assessments; execute audits or desk audits as required.
• Coordinate recalls, product incidents, deviations, CAPAs, and change controls with timely escalation.
• Attend internal and external audits, including government inspections and customer visits.
• Review and approve promotional materials from a local regulatory perspective.
• Elaborate and approve SOPs and Work Instructions per corporate standards.
• Collaborate with local Regulatory Specialist, GM, and Corporate Quality teams; participate in weekly/monthly global meetings.

Skills

Autonomy

Communication

Regulatory interactions

Audits

Corrective actions (CAPAs)

Education

Degree in Pharmacy

Tools

SAP

Job description

Quality Manager Electrical Manufacturing

Showing 432 Quality Manager Electrical Manufacturing Qms Leader jobs in Blacktown

Job Description

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. We believe that diversity adds value to our business, our teams, and our culture. We are committed to equal employment opportunity fostering an inclusive environment where diversity makes us be outstanding. Help us lead one of the world\'s largest pharmaceutical companies. We are a world leader in plasma‑derived medicines with a presence in more than 100 countries, and a growing global team of over 20,000 people. That\'s why we need a Quality Manager like you.

Role Mission

Responsible for ensuring the compliant distribution of medical devices and IVD products in Korea, maintaining the affiliate\'s Quality Management System, and acting as the key local contact for quality, regulatory, and product‑related matters while reporting directly to Corporate Quality in Spain.

What your responsibilities will be

• You will implement, maintain, and continuously improve the affiliate\'s Quality System in alignment with corporate policies and Korean regulatory requirements.
• You will manage product distribution activities (storage, shipping, transport) and ensure all necessary licenses remain valid and up to date.
• You will act as the in‑country quality contact for customers, distributors, and authorities, coordinating complaint management with Grifols manufacturing sites and ensuring proper follow‑up.
• You will qualify suppliers, perform periodic assessments, and execute audits or desk audits when required.
• You will coordinate recalls, product incidents, deviations, CAPAs, and change controls, ensuring timely escalation and documentation.
• You will attend internal and external audits, including government inspections and customer visits.
• You will review and approve promotional materials from a local regulatory perspective.
• You will elaborate and approve SOPs and Work Instructions according to corporate standards.
• You will collaborate closely with the local Regulatory Specialist, the General Manager, and Corporate Quality teams, participating in weekly and monthly global meetings.

Who you are

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, education, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Skills - strong autonomy, ability to operate in a corporate environment, solid communication skills in English, strong understanding of quality systems, capacity to manage deviations and corrective actions, experience with audits and regulatory interactions, ability to escalate issues appropriately.
• Qualifications - 3+ years of experience in Quality or Regulatory roles within a multinational environment; experience with medical devices or IVDs preferred; experience implementing or maintaining a Quality System (ISO 9001 desirable).
• Education - Degree in Pharmacy preferred (not mandatory).
• IT Skills - advanced MS Office user; SAP experience preferred.
• Languages - Korean speaker; fluent in English.

What we offer

Grifols is an equal opportunity employer. Grifols is fully aware that its employees are one of its major assets. We are committed to maintaining an atmosphere that encourages all our employees to develop their professional careers in an excellent working environment.

Information about Grifols is available at . If you are interested in joining our company and you have what it takes for such an exciting position, then don\'t hesitate to apply! We look forward to receiving your application.

We believe in diverse talent and want to remove any barriers that may hinder your participation. If you require any adjustments in our selection process, please do not hesitate to inform us when applying. We are here to help.

Grifols is an equal opportunity employer.
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Type: Regular Full-Time
Job Category: Quality

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