Quality engineer Work, Jobs in Symington Ka1 (with Salaries)

Quality Engineer - NCR/CAPA
Terumo Aortic —Inchinnan
- £33,000 - £40,000 a year
- Engineering
- Analysis skills
- Continuous improvement
Quick apply
11d
Customer Quality Engineer
Peak International Group —Renfrew
- £0.01 a year
- Continuous improvement
- Organisational skills
Quick apply
Senior Project Engineer
Malin Group —Glasgow
- £45,000 - £50,000 a year
- Full-time
- Hybrid work
- Engineering
- Business development
- Training & development
- Annual leave
- Employee assistance programme
Quick apply

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Quality Engineer - NCR/CAPA

Terumo Aortic -
Inchinnan

Quick apply

Job details

Permanent
£33,000 - £40,000 a year
11 days ago

Qualifications

Non-conformance investigation
Six Sigma Green Belt
Stakeholder liaison
Internal quality management system auditing
Engineering
Internal department liaison
Quality management
Complaint handling
Minitab
Statistical analysis
Analysis skills
Continuous improvement
Continuous improvement cycles oversight
Management reporting
Root cause analysis
Internal quality assurance
Lean manufacturing
FDA regulations

Full job description

Terumo Aortic are currently looking to recruit a Quality Engineer (NCR/CAPA) to join our team. This role will provide Quality Engineering support to the NCR/CAPA processes including development of containment plans / investigation plans / root cause analysis / action plans / effectiveness plans and perform NCR/CAPA trend analysis. This is an excellent opportunity to truly make a difference whilst enjoying excellent career development.

The main responsibilities of the role are;

Maintain the management tools (trackers, electronic folder, etc) to ensure audit readiness
Provide consultation and guidance on CAPA / NCR investigation, impact assessments, risk assessments, and ensure implementation of good documentation practices.
Provide guidance and support for effective investigation and root cause analysis for new CAPAs / NCRs, working collaboratively with other functional areas as appropriate
Act as CAPA team owner/facilitator throughout all phases of activities such as initiation, investigation, action plan and effectiveness
Act as NCR team owner/facilitator throughout all phases of activities such as initiation, risk assessment, investigation and disposition.
Provide guidance and support for effective implementation of corrective/preventive actions from CAPA / NCR investigations
Provide guidance and support for robust effectiveness measurement of CAPA / NCR actions
Maintain communication channels with the CAPA / NCR owners regarding time frames and progression updates.
Support development of solution verification tools to validate CAPA / NCR action plans
Working with other functional areas as appropriate, ensure appropriate containment actions are defined and communicated
Generate and maintain trending data for the CAPA / NCR process and publish as part of QMS KPI dashboard Provide trending data and reports upon request to senior management, functional managers, regulatory authorities and customers
Provide data trending information and status updates to the respective CAPA and NCR Review Boards
In conjunction with the Risk Team, provide QE input to dFMEAs and pFMEAs, particularly with respect to CAPA / NCR data
Identifying opportunities to improve processes through use of Lean Methodology or operational excellence principle and tools.
Work towards meeting departmental and facility objectives
Participate in facility Internal Audit programme

The successful candidate will possess;

Relevant science / engineering degree
Six Sigma qualified – minimally Green Belt level (desirable)
Knowledge and understanding of applicable regulations especially with regards to Non Conformance, CAPA, Root Cause Analysis and Trending
Class III medical device knowledge (desirable)
Proven experience of working in a global company within a regulated industry, preferably medical device or pharmaceutical manufacturing
Working knowledge of Minitab or similar statistical tool (desirable)
Experience of FDA regulations
Thorough knowledge of regulatory standards, Quality Management Systems and global regulations for medical devices
Strong analytical and problem-solving skills, including appropriate use of statistical techniques
Proven ability to manage and prioritise work load, meet deadlines and work in a pressurised environment
Must be able to work cross-functionally and be able to lead teams CAPA / NCR Quality Engineers to complete appropriate CAPAs / NCRs to effective timely closure.
Must be able to influence change with objective information and well-structured communications.
Must be able to work cross-functionally and be able to lead teams Complaints quality Engineers and Investigators to complete appropriate complaints documentation for products and processes.

Quick apply

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