We are currently looking for a Senior Quality Engineer to join our team. The ideal candidate must have a minimum of 5 years experience within all aspects of Quality. Specific experience of Supplier Control would be an advantage.
As a senior quality engineer you will be responsible for dealing with day to day issues as they arise within the Manufacturing Environment to assure product Quality is maintained at all times with regard to outgoing product quality and on line quality assurance.
Key Responsibilities: Demonstrates a thorough understanding of quality standards, including MDD, ISO13485, 21CFR 820, 21CFR 210/211 Contributes to the development, maintenance and improvements of Supplier Control policies and procedures Provides guidance to other functional areas in applying Supplier controls quality system requirements Identifies and resolves exceptions to work practices. Works with product line engineering to assess and address material quality issues as a result of issues occurring post production Summarizes, analyses, draws conclusions and makes appropriate decisions from test results or other process related findings Contributes to and participates in Management Reviews and the associated Feeder System Reviews Acts as a leader of quality within the area constantly promoting awareness of best industry practices Assists in establishing and implementing improvement projects and goals Participation in and leadership of CAPA teams Subject matter expert for the area during external audits Approval of change requests for product, process and quality system changes Monitoring of key quality metrics in areas of responsibility to identify improvement opportunities and as input to Management review
Qualifications and Experience:
Bachelors Degree in Engineering, Science, Quality Assurance (Hetac level 8) OR equivalent At minimum 5 years experience in an Engineering / Quality role in a pharmaceutical/medical device environment with direct experience in a GMP regulated environment a distinct advantage. Experience in FDA or notified body audits essential. Strong team member with the ability to identify and drive quality improvements. Ability to work with minimum supervision. Strong analytical and problem-solving skills Ability to organize, plan and execute multiple tasks to a schedule Excellent interpersonal and communication skills
