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.

Terumo Aortic has been manufacturing products to help save patients’ lives from its facility at Inchinnan near Paisley for 40 years now. Our associates are hands on in the fight to treat several cardiovascular conditions by helping to manufacture our innovative range of grafts.

You don’t have to have a background in medical devices, we will provide extensive training to help you become a highly skilled sewing operative who can be proud of the products which you make and the impact they have on the patients who receive them.

Key responsibilities and duties will include

• Undertake manufacturing duties as specified by the Production Supervisor.
• Follow good manufacturing processes as defined in procedures and specifications.
• Work towards meeting quality objectives.
• Promote 5S and efficient manufacturing processes.

Skills and experience desired:

• Hand or machine sewing experience would be advantageous (Full training will be given)
• Ability to follow procedures and specifications within stringent guidelines.
• Ability to learn new processes quickly.
• High level of dexterity.
• Experience from a manufacturing environment.

The ideal candidate should be self-motivated with a positive attitude and excellent communication skills. You will be a team player and have good attention to detail.

We operate a variety of 37 hour per week shift patterns between Monday and Friday, creating a positive work life balance.

As well as competitive salaries and a great bonus scheme, we provide pension and life insurance schemes to help safe guard your future and those closest to you. We also offer a generous holiday entitlement to our associates and many other benefits including a subsidised canteen and retailer discounts.

Being part of the Japanese Terumo Corporation, which employs over 25,000 people worldwide and with another manufacturing facility in Florida, a career at Terumo Aortic offers a wide range of opportunities to progress and realise your potential whilst contributing to the company mission of “Contributing to society through healthcare”.

Key Duties

• Liaise with OEM customer on specification, prototyping, design, development and introduction of new OEM products into manufacturing, in accordance with OEM and ECO procedures.
• Liaise with all relevant departments on the transfer of new OEM products into manufacturing and ensure that all the appropriate specifications and packaging materials are available.
• Review production planning schedule to ensure adequate hours are available and monitor schedule on an ongoing basis.
• Assist in planning of equipment and labour requirements to ensure sales forecast is achieved.
• Support OEM customers with packaging queries and issues.
• Update and maintain OEM documentation.
• Improve OEM packaging and change processes.
• Validate equipment and processes within manufacturing.
• Assist OEM customers in the development of new processes, equipment and products to ensure they are fit for purpose.
• Review and update BOMs and routings.

Qualifications & Experience

• Minimum HND or equivalent in relevant engineering discipline.
• Experience using a technical drawing CAD package (SolidWorks/AutoCAD) is preferred.
• Good working knowledge of Microsoft Office.
• Clear communication skills.
• Adept at handling multiple projects.
• Strong team-working abilities.
• Relevant previous experience in a high-quality manufacturing environment.
• Thorough knowledge of FMEA and DOE processes.
• Knowledge and ability to demonstrate use of Lean techniques and methodology, including 5S, SMED and VSM.
• Ability to understand current processes and use lean six sigma manufacturing tools to implement measurable improvements.
• Proven project management experience.
• History of goal achievement to tight timescales.
• Knowledge of production/process equipment.

The main responsibilities are;

• Ensure objectives on Health and Safety are delivered.
• Conduct required stock checks, ensuring accurate completion and update of relevant systems to reflect actual quantities. 
• Investigate stock deviations and highlight to warehouse and planning teams as appropriate.
• Prepare and action stock requests for production areas.
• Support the Manufacturing & Shift Leads in the execution of the business plan (S&OP plan).
• Work in partnership with production areas, Manufacturing and Shift Leads to maintain a balanced process flow, maximise output efficiencies and support OTTP.
• Ensure key internal and external customers receive the level of service required to hit the plan.
• Develop close, collaborative relationships with internal functional teams to ensure standardised support processes are in place and meet their needs.
• Respond to changes in demands in a timely manner.  
• Allocation of W/O to Process areas by due date sequence to maintain resource utilisation & balanced process.
• Maintain adherence to plan highlighting deviations from schedule for resolution.
• Communicate WO priorities & schedule sequencing to relevant Manufacturing & Shift Leads.
• Support manufacture of all products in-line with quality requirements.
• Manage and report the key operational metrics to maintain WIP accuracy.
• Attend production planning meetings, providing updates as required.
• Support improvement activities, including but not limited to, 5S; Kaizen Events; Continuous Improvement activities.
• Perform other tasks as needed in support of key objectives.
• Assume other responsibilities from time-to-time to support plant objectives and personal career development.

Qualifications & Experience;

• Experience of working in a manufacturing environment
• Experience with a manufacturing shop floor data collection software, such as SAP & MFG Pro.
• Experiencing of managing production workflow.
• Understanding of Lean Tools and their applications in Manufacturing.
• Working knowledge of MS Office, including MS Word and Excel.