Site CAPA Leader
Website BD Medical / BD Pharmaceutical
Job ID R-393186
Date posted 03/23/2021
To assist the site CAPA owners, investigators and approvers on each and every CAPA.
Provide training and guidance on the CAPA process to the organization.
Monitor every CAPA at each phase.
Report to Management status and risks on the CAPAs
- Essential responsibilities include but are not limited to:
- Owner of the CAPA process
- Good understanding of the Manufacturing processes and Quality System.
- Promote/ Leading / mentoring / conducting quality improvement projects thru continuous improvement initiatives.
- May obtain Green/Black Belt Certification.
- Assist in the acceptance and validation of process equipment.
- Review and develop changes in existing or proposed processes or requirements to achieve optimum performance and quality, cost.
- Assume a role of leadership in analyzing and resolving issues, which lead to strengthening the CAPAs effectiveness.
- Stay informed as to the latest requirements of federal regulations and corporate policies regarding medical devices.
- Lead and ensure regulatory compliance is met and that the manufacturing unit is trained on all requirements.
- Provide support and guidance on quality/ process improvements.
- Ensure that all company safety rules and regulations are followed and promote general plant safety.
- Assist in internal/ external audits as needed.
- Other duties, as assigned
KNOWLEDGE AND EXPERIENCE
Required: Bachelor of Science degree
Required: 5 years manufacturing experience with broad background in manufacturing processes
- 3 years CAPA Process
- 2 years Quality manufacturing experience
- Proven history of product / process improvements utilizing Green/ Black Belt/Six Sigma techniques.
- Ability to generate validation protocols, which comply with the globalization standardization initiative.
- Experience working in medical device manufacturing industry
- Experience in metrology and gauge fixture design preferred.
- Experience working with high performing work teams desired
- Certificate in Quality Auditing
- 3 years practical GMP / Medical Device manufacturing experience.Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Primary Work Location
USA NE – Columbus (West)
To apply for this job please visit jobs.bd.com.