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What Quality Control 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 Control is responsible for the analysis or inspection of materials, components, products or processes for compliance with specifications and standards.
Job Summary
The Spec, Quality Control ensures the safety, quality, and efficiency of device manufacturing. The Spec, Quality Control inspects products and components prior to their release and documents results of testing. This job communicates with internal stakeholders regarding product clearance and issues and helps maintain and update the Technical Management standard operating procedures.
Job Responsibilities
- Conducts routine clearance for new and modified products by applying in-depth knowledge of regulations and testing methodologies. Compiles and inputs data, documents and processes findings, and interprets results. Communicates results of testing to requestors and escalates issues as appropriate.
- Completes applicable documents following clearance, such as 510k submissions and European Union registrations, needed for the release of a product or component to the field.
- Participates in the establishment of future testing methods and standard operating procedures. Assists in annual auditing of Technical Management processes.
- Coordinates contracted laboratory operations in clearance and testing. Participates in the periodic auditing and evaluation of lab service suppliers.
- Conducts testing to support label claims or special projects, such as cleaning validations and stability of products.
- Provides technical guidance and training to others on biocompatibility and toxicology test methodologies, SOPs and quality guidelines.
Qualifications
- 0-2 years of experience preferred
- BA, BS or equivalent experience in related field preferred
What is expected of you and others at this level
- Applies basic concepts, principles and technical capabilities to perform routine tasks
- Works on projects of limited scope and complexity
- Follows established procedures to resolve readily identifiable technical problems
- Works under direct supervision and receives detailed instructions
- Develops competence by performing structured work assignments
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 ensuring employees can 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.
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