Quality Engineer

Job description

TheQuality Engineer will provide quality expertise to help our site in Sudbury, Suffolk meet divisional strategic quality & business goals.They will elaborate and analyse Quality concepts, methods, tools and procedures as part of an effective Quality Management System.
The Quality Engineerwill also provide Quality Management input to the global Commodity, Engineering, ManaufactringTeams, they will co-ordinate supplier corrective actions and supplier development activities in association with the other relevant teams.

What are my responsibilities?

· Data collection, production of data, analysis, interpretation & reporting
· SCAR, CAPAcreation & Issue Resolution investigation, administration & monitoring
· Deviation,RA& Non Conformance administration & monitoring
· Quality document creation, issue, control, review, approval and archive (QCP’s, Procedures, Quality Agreements)
· External Supplier visits and Quality Audits (QMS and Process)
· Preparing for and hosting suppliers, regulatory & notified body audits
· Representation of Supplier Quality Assurance team at site meetings (Manufacturing, Escalation, SWARM, KT, PST/PHT)
· Quality related improvement projects and quality initiatives
· Champions a Zero Defects Culture
· Manufacturing quality support
· Support internal QMS audit plan

Desired Attributes

· Implements or administers Quality policies, guidelines, programs and standards, in an assigned area of work, and assigned team.
· Contributes to departments budget planning and completes Quality related reporting.
· Advises management, suppliers and other stakeholders in Quality related issues
· Plans and completes assigned Quality `Supplier Development’ projects
· Ensures adherence to defined procedures at all stages of quality assurance processes
· Prepares Quality related analyses, concepts, methods and tools, for respective management to decide
· Maintains and improves quality standards in Quality testing, operations and processes
· Prepares alignment measures for existing Quality systems and processes
· Designs, maintains and improves specific Quality requirements, specification, test methods and concepts; communicates to stakeholders including suppliers, designers, engineering and manufacturing
· Analyses workflow environment and trends testing data in order to propose improvements to management
· Ensures effective cooperation with both internal and external stakeholders; clarifies issues
· May oversee specific activities of Quality personnel, assign tests and tasks to team members, leading the team as and when required

What do I need to qualify for the role?

· Engineering Qualification
· Quality Assurance Qualifications
· Qualified Lead Quality Assessor (desireable)
· Good Working knowledge of global healthcare regulations & standards such as FDA & ISO
· Familiarity with a variety of manufacturing environments
· Engineering background/Qualification beneficial
· Excellent Communication Skills, methodical approach, IT skills
· Demonstrable experience in quality project management or manufacturing quality improvement initiatives
· Regulatory affairs and/or experience in Healthcare industry experience will be a benefit
· Ability to analyse data and report accordingly (CPK, FMEA, Statistical Analysis, Approved Quality Sampling Plans)

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