Job Description Summary
Senior Quality Engineer
The Senior Quality Engineer will have the following duties or responsibilities are not limited to those listed below. The job holder is expected to perform other duties and responsibilities as assigned.
Provides quality engineering leadership to key business projects for BD Eysins;
Supports engineering projects by providing quality engineering input pertaining to Design Transfer to Production (DTP), Design Verification and Validation (V&V), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities;
Supports the development and implementation of sampling plans, statistical analysis, measurement, test and inspection procedures at associated contract manufacturers for Eysins contract manufacturers;
Collects, analyzes (using statistically valid methods) and reports key (quality) performance indicators to key stakeholders (internal and external) and identifies areas for improvement (product design, manufacturing process, equipment and/or the QMS), initiates and lead continuous improvement projects by applying relevant methods of contract manufacturers and suppliers under BD Eysins;
Conduct supplier quality audits, including closing out audit findings, creating audit finding reports and determine proper corrective and preventive actions of contract manufacturers and suppliers under BD Eysins;
Supports quality related projects for example implementation of new / revised standards such as MDR, related to products where BD Eysins is the Legal Manufacturer.
Supports Post Market Surveillance Activities related to BD Eysins MDS portfolio.
Supports risk management file remediation for BD Eysins MDS portfolio.
To be successful in this role the Senior Quality Engineer will have the following skills and experience.
Sound knowledge of ISO 13485 and Medical Device Directive 93/42/EEC requirements, MDR;
Good written and oral communication;
Good prioritizing, organization, interpersonal, communication and analytical skills;
Work independently with minimum supervision, across multiple geographics and functions;
Good computer skills (MS Office);
Basic knowledge of lean methods (5S, Lean Six SigmaSS, Kaizen) prefered;
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists;
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form;
Basic knowledge of US FDA 21 CFR 820 requirements preferred;
Strong sense of customer focus.
Strong analytical skills
Ability to scope and manage projects
Proactive and the ability to take initiative with a ‘can do’ attitude
Ability to effectively present information to management, public groups and/or customers
Ability to work autonomously and to appropriately prioritise workload independently
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Primary Work Location
GBR Winnersh - Eskdale Road