Join to apply for the Quality Engineer role at Bendigo Advertiser
What Quality Engineering contributes to Cardinal Health: Quality develops and implements quality policies, procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Engineering manages product and service quality planning, evaluation, and control. This job family works cross-functionally in the development and implementation of prevention-based methodologies used in designing, manufacturing, testing, and correction of products and services.
Overview
The Quality Engineer is responsible for leading and managing quality assurance of medical device products and processes. This role will lead quality and compliance activities for Cardinal Health which includes diverse medical devices. The Quality Engineer ensures that product quality and regulatory compliance goals are met for new product development projects and released products.
Responsibilities
* Apply comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects.
* Ensure product compliance to ISO 13485 and 21 CFR 820 Quality System Regulations by providing support for interpretation of regulations, performing gap analyses, and leading activities to implement improvements.
* Involve in continuous improvement activities.
* Identify and implement data analysis, system conformance, and ensure finished goods meet standards and specifications; implement and drive changes where needed.
* Support Regulatory, Medical Affairs, Research and Development, Manufacturing, Supplier, Audit, CAPA, and Program Management teams as required.
* Perform activities related to Risk Management Plan, Hazard Identification Worksheet, Risk Analysis Chart, and Risk Management Report.
* Contribute to the development of policies and procedures.
* Develop technical solutions to a wide range of difficult problems; solutions are innovative and aligned with organizational objectives.
* Complete tasks independently after receiving general guidance on new projects.
Qualifications
* 4-8 years of experience preferred.
* Bachelor's degree in a related field, or equivalent work experience, preferred.
* Applied knowledge of quality systems and regulatory requirements; ability to work on complex projects and mentor others as needed.
What is expected of you and others at this level
* Applies comprehensive knowledge and understanding to perform varied tasks and projects.
* May contribute to the development of policies and procedures.
* Works on complex projects of large scope and develops technical solutions to difficult problems; innovative and aligned with objectives.
* Completes work independently with general guidance on new projects; work is reviewed for objective achievement.
Beneficiary notes
Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply. Cardinal Health supports an inclusive workplace that values diversity of thought, experience, and background. We celebrate the power of our differences to create better solutions for our customers by enabling employees to be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status, or any other status protected by federal, state, or local law.
Job details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance
* Industries: Newspaper Publishing
Get notified about new Quality Engineer jobs in Bar Beach, New South Wales, Australia .
Bar Beach, New South Wales, Australia
Newcastle, New South Wales, Australia
Tomago, New South Wales, Australia
Newcastle, New South Wales, Australia
Bar Beach, New South Wales, Australia
Newcastle, New South Wales, Australia
#J-18808-Ljbffr