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You will be updated with latest job alerts via email5years
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Salary Not Disclosed
1 Vacancy
- Approve quality system documentation and engage in cross-functional development teams for the creation and launch of new products.
- Take part in and lead cross-functional improvement projects and CAPAs, and offers technical support to the QC department.
- Guide the introduction of new or enhanced products and facilitate the transfer of technology from development to commercialization, all with a keen focus on maintaining high-quality standards.
- Examine the outcomes of Risk Analyses and spearhead cross-functional initiatives to pinpoint suitable risk mitigation actions.
- Creates and sustains inspection plans utilizing suitable methodologies to guarantee that products adhere to specifications and are safe and effective for use.
- Recognize and execute opportunities for continuous improvement.
- Collaborate and coordinate activities with other departments, external vendors, and customers.
- Aid or take the lead in swiftly implementing Quality-related projects, including resolving non-conformances, investigating complaints, and implementing Corrective and Preventive Actions (CAPA), as well as Process Validations.
- Must have a minimum of 3 years experience in the medical device industry.
- Proficient understanding of medical device Design Control and Quality System requirements, including 21CFR820, ISO13485, and ISO14971.
- Possesses strong technical skills with a proven ability to offer solutions to various technical problems of moderate scope and complexity.
- Demonstrated experience and comprehension in the use of statistical tools.
- Capable of independently managing projects and leading cross-functional teams.
- Strong proficiency in both written and verbal communication, coupled with the ability to multitask in a fast-paced environment.
- Experience in supplier auditing.
Full Time