As directed by the Quality Director, the Senior Staff Quality Systems Engineer is accountable for support of the continued development, improvement and implementation, and compliance of the Quality Systems. This position actively participates in Corporate quality network teams with process improvement and continuous improvement activities. This role has a key objective of identifying and addressing potential and existing quality and regulatory issues as well as streamlining quality system procedures to ensure an effective quality management system.
Will be responsible for maintaining and upgrading the quality system procedures, processes, and documentation by:
- Working with the persons responsible to amend / improve procedures, processes and work instructions.
- Working with individuals to evaluate risk assessment of non-conformance.
- Creating, maintaining and reporting relevant quality system metrics.
- Addressing actions from regulatory and customer audits that concern the quality system.
- Interfaces with BD manufacturing plants and other business functions to ensure complete, consistent, and timely implementation of process improvements and collection of quality system metrics
- Bachelor's Degree required
- Certified ISO 9001/13485 auditor
- Strong knowledge of Quality Metrics and QMS processes
- Minimum 15 years of experience supporting Management Controls/Quality Metrics for medical devices
- Exposed to internal and external audits as an auditor and/or auditee
- Extensive knowledge of applicable regulatory and industry standards (21 CFR 820, ISO 13485, MDD, MDR, ISO 14971, etc.)
- Good technical writing and communication skills