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Staff I Engineer, Quality Systems Andover United States,
Becton Dickinson (company)
Posted on : 12 August 2017
As directed by the Associate Quality Director, the Staff Quality Engineer I is accountable for support in the continued development, improvement, and expansion of the Diabetes Care WW Quality Management System as well as maintaining compliance with regulations, standards, and Corporate requirements. This position provides collaborative support to quality system leadership and may work with other functions within the organization including Operations, Quality, R&D, Procurement, Marketing, Regulatory and Medical in addition to corporate functions, regulatory agencies and suppliers.
- Coordinate quality systems and processes to ensure compliance with Quality System and regulatory requirements and promote quality improvements.
- Develop and make updates to applicable Site / Unit procedures and policies.
- Provide a quality review on a range of quality documentation including Unit Policies, Procedures, Investigations, Change Controls, GMP records and other Quality Management Systems Documentation as required.
- Lead unit-level quality system processes and systems (SAP, TrackWise, ECC, DMS, etc) for CAPA, audit, Quality notification, calibration, supplier management, document and change control.
- Ensure investigations are conducted and adequately resolved in a timely manner with appropriate CAPAs in place to prevent reoccurrence of issues.
- Conducts or leads internal audits and supplier audits.
Experience and Education:
- A minimum of 8 years relevant experience or a combination of higher education and relevant experience.
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