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Edwards Lifesciences Senior Quality Specialist in North Ryde, Australia

Currently looking to hire a Senior QA specialist based in Sydney. In this role we are looking for someone who can lead our QA practice/standards and be an advocate for quality across all different BU’s including THV, Surgical, Critical Care Technology and isn’t afraid to get their hands dirty in the medical device industry. Best described with a day to day split of 30% leadership 20 inspections and 50%execution of governance, compliance and policies across ANZ.

Key Responsibilities:

• DC Quality Management

a)Implement and maintain Label Management Process and Over-Labeling Process at 3PL, to eliminate Quality Risk related to Local Over-Labeling Activities.

b)Implement and maintain Product Inspection Process and Product Release Process, including Imported Finished Goods, Over-Labeled Products, and Returned Products

c)Implement and track Quality Hold in 3PL

d)Drive improvement for 3PL Quality Management System, implement and maintain Quality Agreements

• Quality Management System

a)Develop and maintain Quality Management System according to Edwards and local regulatory requirements

b)Work with cross-functional team on NCR, CAPA, and Product Risk Assessment (PRA) Process, including the required document preparation in a timely manner. Follow up CAPA and SCAR action plan

c)Provide Quality Training

d)Implement Supplier Control Process

• Post Market Quality Assurance

a)Product Complaint Handling Process, includes receiving and reporting complaints to CH Center, following up Complaint Investigation, and preparing Customer Response Letter in Local Language

b)MDR process: Assess reportable complaints and report ADE to Competency Authority according to Local Regulation

c)Field Corrective Action Process, includes operations in JDE system. Act as Local FCA Coordinator

• Set up Country Quality Management System under Manager's supervision, to meet Local Regulatory Requirements, under Edwards Global Quality Management System

• Participate in audit program

• Develop, lead, and/or contribute to the implementation of proposed modifications to resolve open issues, as a part of cross-functional / project team, to bring the process knowledge

• Respond to internal customers data requests and external/internal auditors or inspections to Edwards Quality Management System

• Other incidental duties: Implement continuous improvement program or project assigned by manager

Education and Experience:

Bachelor's Degree in related field, 5 Years experience previous related experience Required and

• Experience in a quality and/or manufacturing environment in the medical device industry Preferred

Additional Skills:

• Proven expertise in MS Office Suite

• Excellent written and verbal communication skills in Local Language including negotiating and relationship management skills

• Strong written and verbal communication skills in English

• Strong problem-solving and critical thinking skills

• Full knowledge and understanding of Edwards policies, procedures, and guidelines relevant to quality systems

• Full knowledge of medical or pharmaceutical regulations as relating to documentation (e.g. Good Documentation Practices)

• Full understanding of medical devices regulations (e.g., ISO13485, Local Regulatory Requirements)

• Strict attention to detail

• Ability to interact professionally with all organizational levels

• Ability to manage competing priorities in a fast paced environment

• Work is performed independently on more complex projects and/or lines of work and reviewed for accuracy and soundness

• Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.

For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.