Quality Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Title: Quality Engineer

Location: Inchinnan

Position Objective:

We are recruiting for a Quality Engineer to join our small team onsite in Inchinnan. The role will establish and maintain outstanding Quality Systems that align with ISO13485 and FDA 21CFR Part 820. Assure compliance with both internal and external specifications and standards. Actively lead data collection, trend analysis, investigations, and improvements to processes, products, and systems.

Essential Functions:

1. Collaborate closely with Production, Technical, and Manufacturing Engineering teams to resolve quality-related issues from customer complaints/concerns and internal incidents. Facilitate investigations and resolution of related quality issues.
2. Partner with technical support and manufacturing to build and modify methods and procedures, ensuring that appropriate processes, products, materials, and manufacturing equipment meet stringent standards.
3. Aim to improve efficiency in procedures and processes without compromising quality. Identify and implement improvement opportunities across the operational facility.
4. Conduct statistical analysis to identify trends, investigate root causes, and lead corrective actions for processes and products.
5. Maintain a detailed knowledge of Regulatory and Quality System requirements (ISO13485/FDA CFR).
6. Apply the Trackwise system for handling non-conformances, deviations, and Corrective and Preventative Actions (CAPA).
7. Apply the Agile system for change controls and provide training, support, and facilitate the change control process within operations.
8. Participate actively on the Internal Quality Audit team.
9. Ensure compliance with both in-house and external specifications and standards, such as GMPs and ISO regulations, and approve dispositions for non-conformances on raw materials and finished goods.
10. Provide training and support to other QA staff as required.
11. Perform independently with minimal direction, exercising considerable latitude in resolving technical objectives and solutions to complex problems.
12. May perform additional related duties as required and assigned.

Education:

A Bachelor's or Master's degree in chemistry, biochemistry, microbiology, engineering, or a related field is required.

Experience:

1. Related quality experience and demonstrated knowledge of compliance, quality, and scientific principles is required.
2. Proficiency in Six Sigma tools and methodology is essential.
3. Must have strong communication skills, work well in teams, and interact across all levels.
4. Must be a self-starter who can take general concepts and direction and produce outstanding results.
5. Additionally, must function effectively and efficiently in a global, multi-site organisation.

Contacts:

Will collaborate extensively with all other departments on matters relating to quality and service to uphold the company's dedication to customer happiness. This involves working with people at all levels within the organisation, as well as external customers and regulatory bodies.