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Quality Engineer III Job Description

Position Objective:

Supports and maintains appropriate Quality Systems consistent with ISO13485 and FDA 21CFR Part 820. Assures compliance to in-house and/or external specifications and standards. Actively leads the data collection, trend analysis, investigation and improvements to processes, products and systems.

Essential Functions:

Work closely and collaboratively with Production, Technical and Manufacturing Engineering to resolve quality related issues arising from customer complaints/concerns and internal incidents. Responsible for the facilitation of investigations and resolution of related quality issues ensuring structured root cause analysis and robust CAPA plan implementation. Leads PPI activities at the site including Kaizen events and supporting the other Quality team members on process improvement activities. Is responsible for the site change control system including process risk assessment in the form of FMEA and HACCP tools. Supports customer & 3rd party audits. Performs statistical analysis to analyze trends, pro-actively leading any potential issues. Works with manufacturing to investigate emerging trends, and lead corrective actions for processes and products. Maintain understanding of Regulatory and Quality System requirements (ISO13485/FDA CFR). May Lead site CAPA system and complaint management process and provides monthly reviews to senior management. Participates on the Internal Quality Audit team. Assures compliance to standards, such as GMPs and ISO regulations, and approves disposition for non-conformances on raw materials and finished goods. Leads Quality related projects and represents quality as and when required on projects across operations. Represents the site quality systems to customers in face meetings or through written and verbal correspondence. Provide training, support and mentorship to other Quality Engineering Staff. Perform independently without continual direction and exercise considerable latitude in resolving technical objectives and solutions to problems. Will be required to perform other related tasks.

Education:

Requires a Bachelors/Masters degree in chemistry, biochemistry, microbiology, engineering or related field.

Experience:

A minimum of 5 years related quality experience and confirmed understanding of compliance, quality and scientific principles. Should be proficient in Six Sigma tools and methodology.

Strong oral and written communication skills with a shown ability to work in a multi-functional company and to efficiently engage with all levels in the company.

Must be a self-starter who can take general concepts and direction and produce desirable results. Also must function effectively and efficiently in a global, multi-site organization

Contacts:

Will collaborate extensively with all other departments on matters relating to quality and service in order to uphold the Company’s commitment to Customer satisfaction. This involves working with people at all levels within the organisation as well as external customers and regulatory bodies.

Working Conditions:

Works in an office environment but may be required to spend some time in manufacturing and the warehouse.