Quality Engineer - Medical Device Manufacturing & CI

Kindeva Drug Delivery Company; Clitheroe; On-site; GBP 32,000 - 52,000; Full time

Benefits offered by this job

Company pension scheme (up to 10% dev)

25 days holiday + bank holidays

Private Medical Insurance

Life assurance

Employee Assistance Program

Job summary

Kindeva Drug Delivery Company in the UK is seeking a Manufacturing Technology professional to support the production and assembly of precision components for pulmonary/inhalation devices. You will lead investigations across the full production lifecycle, applying data analysis and CI tools, developing SOPs and validation protocols, and ensuring compliance with GMP, ISO 9001, and regulatory requirements.

The role emphasizes cross-functional collaboration, prioritizing multiple projects, and

Qualifications

• 2+ years in a manufacturing environment with process/quality focus.
• Degree in Manufacturing, Chemical, Pharmaceutical Engineering, or related.
• Experience with GMP, QA, Validation, ISO 9001, QMS.
• Understanding of cGMP, FDA, EMA regulatory expectations.

Responsibilities

• Lead product quality investigations and implement corrective actions.
• Validate new and existing products and processes.
• Identify cost reduction and quality improvement opportunities via CI projects.
• Manage multiple projects/investigations and coordinate with stakeholders.
• Apply data analysis tools (Minitab) and continuous improvement methods.
• Provide technical troubleshooting and drive process improvements.
• Develop SOPs, validation protocols, reports, and change controls.
• Ensure compliance with industry regulations and safety practices.

Skills

2+ years manufacturing experience

GMP knowledge

QA & Validation

Project management

ISO 9001 & QMS

Lean / Six Sigma

Regulatory knowledge (cGMP, FDA, EMA)

MS Word & Excel

Data analysis (Minitab)

Education

Bachelor's degree in Manufacturing, Chemical, Pharmaceutical Engineering or related field

Tools

Minitab

Excel

Job description

Kindeva Drug Delivery Company in the UK is seeking a Manufacturing Technology professional to support the production and assembly of precision components for pulmonary/inhalation devices. You will lead investigations across the full production lifecycle, applying data analysis and CI tools, developing SOPs and validation protocols, and ensuring compliance with GMP, ISO 9001, and regulatory requirements.

The role emphasizes cross-functional collaboration, prioritizing multiple projects, and