Quality Systems Engineer

Carbon60 are working with a fantastic client who are based in Hamble, Southampton.

The company specialise in the manufacturing of high-performance, solid-state laser systems and fiber optics for scientific, analytical and metrology applications are currently recruiting for a Quality Systems Engineer to join their growing team.

It really is an exciting time to join this company!

Salary £35,000 - £45,000

Hours Monday to Friday (generally 7:30 - 4 / 8- 5 - depending on work required)

Reporting to the Quality Manager, this role is responsible for ensuring that product and business system processes meet regulatory and customer quality standards. Responsible for managing the internal audit schedule and conducting internal audits in line with relevant quality standards. Responsible for identifying and raising quality issues and working to resolve them, including working directly with customers and Suppliers. Work in a team environment to develop and implement quality best practices and support continuous improvement.

Main Responsibilities

Business System Development

• Lead and support development and maintenance of business management systems, procedures and

documentation

• Lead and support certification to new or existing Regulatory Standards (e.g. ISO9001:2015)
• Conduct system administration and work to streamline quality and business processes

Quality Assurance & Auditing

• Manage the internal audit schedule and carry out internal process & product audits in line with ISO 9001:2015 requirements
• Act as Action Progress Chaser, ensuring that containment, corrective and preventive actions are closed out on time or escalated for re-prioritisation
• Work with internal and external stakeholders to resolve quality issues that arise to prevent compromising standards
• Act as backup to the Supplier Quality Engineer to support Supply Chain Quality non-conformance and development activities - Supplier audits, reject management, inspection etc.
• Support compliance activities - assist Engineering & Operations in the preparation & issuing of compliance reports
• Investigate customer complaints, report findings and non-compliance's and implement corrective actions
• Carry out data analysis and report on trends on Key Performance Indicators (KPIs) (e.g. Scrap, Warranty etc.)
• Preparation of internal and external Quality Reports and presentations as required

Quality Engineering Support

• Provide Quality Engineering support to Manufacturing to maintain OTD and Quality requirements
• Review product concession and deviation notices for suitability prior to approval
• Generate and maintain documentation such as SOP's, calibration, test procedures and Inspection and Control

Plans

• Control of Customer supplied documentation, Standards library and Customer portal access
• Ensure batch and configuration reports correctly issued for shipped product
• Manage reporting of all Customer Returns (RMAs) to ensure they are processed as required
• Support design & development activities - assist Engineering teams to ensure that designs are appropriately

reviewed, verified and validated throughout the development process

• Ensure all manufacturing change and NPI embeds Quality methodologies (Human Factors, Poka-Yoke, MSA etc)
• Lead Root Cause Analysis and Corrective Action (RCCA / CAPA) methodologies such as DMAIC, 8D, 5W & 6M etc

General:

• Train both team and broader organisation members
• Lead and / or support groups of technicians or engineers in quality activities
• Perform ad hoc tasks as required
• Keep up to date with developments and trends in Quality Best Practices and Regulatory Standards

PERSON SPECIFICATION

Skills, Qualifications and Experience

Essential Desirable

• Experience in a Quality Engineering / Assurance role in a relevant manufacturing industry.
• HND / BTEC / NVQ Level 4 in Engineering or Quality
• ISO 9001:2015 Internal Auditing qualification and internal auditing experience
• Good working knowledge of ISO9001:2015
• Experience of CI Methodologies (5S, LSS etc)
• Experience of working with customers and suppliers
• Knowledge of 8D problem solving, RCCA tools as well as APQP,PPAP and FMEAs
• Ability to write and submit Quality reports and familiar with non conformance management

processes

• Experience of working with ERP systems
• Good working knowledge of Microsoft Office Tools
• Able to interpret manufacturing documentation
• Must abide by Company smoking policy
• ISO9001:2015 Lead Auditor qualification & experience
• Experience in Optical / Mechanical / Electronic / Hi-tech manufacturing / process engineering
• Experience in ISO clean room or similar GMP environments
• Educated to degree level (or equivalent) in Engineering or Quality discipline
• Lean Six Sigma Green or Black Belt Certified
• Good working knowledge of ISO13485, TS16949 or AS9100
• Experience using SAP
• Compliance experience - e.g. previous involvement with certification to FDA/CDRH, UL/CSA, EMC, LVD, knowledge of ROHS, REACH, WEEE & Conflict Minerals
• Membership of an industry related Professional Body would be advantageous

Minimum Competencies

These are the minimum standards we expect from the holder of this job description to display in their role

• Analytical Problem Solving
• Product and Process Knowledge
• Quality Management Systems
• Quality Planning / Control
• Supplier Quality
• Effective use of Statistics
• Concise & accurate in Communications (both written & verbal)
• Excellent time management skills - able to prioritise short-term & long-term workload
• Able to work effectively in isolation or within a team
• Able to provide guidance at management level on own areas of expertise

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.