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Job description

Job Description:
Provide Quality Engineering support to various areas including design verification and validation, production line/receiving inspection support, process validation (IQ/OQ/PQ), process optimization, non-conformance investigation, risk management, and post-market assessment.

Job Responsibilities:

• Partner with Manufacturing Engineers to develop and qualify manufacturing processes.
• Review and approve design changes.
• Provide technical Quality support to ensure new processes/procedures are in compliance with the governing standards and procedures.
• Provide technical Quality support during review of the standards.
• Review of documentation and production records to ensure all product is produced in a compliant manner and ensure all manufacturing records received are reviewed, approved, and filed in compliance with QSRs and ISO standards.
• Creation and approval of test protocols and reports in support of equipment qualifications (IQ/OQ/PQ), design verification, continuous improvement projects, validation activities and Gage RR studies.
• Lead cross-functional teams in the creation and development of risk management documents, Process FMEA and others as required by JenaValve internal procedures.
• Lead cross-functional teams in the generation and implementation of improvement projects.
• Assist in the completion, generation and implementation of the Validation Master Plan and supporting activities.
• Audit the manufacturing line to ensure compliance to governing procedures is being met.
• Execute Internal and External (supplier) audits.
• Maintain applicable equipment, including preventative maintenance and calibration, in line with the relevant SOPs.
• Lead root cause analysis investigations for production related nonconformities and develop and aid in the implementation corrective actions.
• Take on other roles required to support continuous improvement within Quality and manufacturing. Serve as a mentor to more junior Quality Engineers on quality engineering-related
• Support elements of the Quality System such as, but not limited to, Supplier management, CAPAs and post market surveillance programs.

• Bachelor of Science degree in engineering.
• 4 + years medical device Quality/Regulatory experience in a medical device, pharmaceutical or life sciences technology driven company.
• Experience with nonconformance, investigations, root cause analysis, risk analysis and corrective/preventive actions.
• Must be familiar with 21CFR820, ISO 13485, and ISO14971 requirements.

• Can identify work priorities and deploy resources to ensure business needs are met.
• Must be able to work effectively and collaborate within cross-functional teams.
• Must be able to effectively articulate (verbally and in writing) results and conclusions to technical and non- technical personnel.
• Must have strong project management and documentation skills.
• Must take initiative and have the ability to conduct hands-on work.