Quality Engineer

Quality Engineer

Exciting opportunity for an experienced Quality Engineer to join our clients growing business. The Quality Engineer will be responsible for assuring product solutions conform to established requirements and standards through appropriate audit, inspection, and test activities. This includes analysing quality trend data and taking appropriate action; supporting projects on all quality related issues; investigating customer complaints and ensuring an effective and robust quality system which complies with all relevant regulatory requirements. The QE will also be involved in continuous improvement programmes and other projects as required.


Qualifications

• Primary Degree BSc / BEng
• 3+ years’ experience as a Quality Engineer in either Medical Device or Pharmaceutical Industry.

Responsibilities:

• Formulates procedures, specifications, and standards for projects and processes.
• Develops and implements corrective/preventative action plans.
• Manage and maintain business’s quality system ensuring it complies with all relevant regulatory requirements.
• Complete in-depth investigations into customer complaints and implement corrective and preventative actions, as appropriate.
• Supplier management ensuring all suppliers meet the business’s requirements
• Identify and implement effective process control systems to support the development and qualification of projects to meet or exceed internal and external requirements.
• Maintain tools for monitoring and communication of quality system performance metrics on an ongoing basis and rolling up to management review.
• Preparation of Quality reports for Quality meetings and management reviews
• Drive continuous improvement initiatives and quality initiatives.
• Acts as an effective team member in supporting quality disciplines, decisions and practices.
• Apply sound, systematic problem solving methodologies in identifying, prioritizing, communicating and resolving quality issues.
• Partake in both ISO and Customer audits
• Conduct internal quality audits to ISO and GMP requirements

Key Skills & Attributes

• Qualified and experienced Lead Auditor, preferably within the Medical Device Industry would be an advantage
• Experience in carrying our external and internal audits
• Excellent Computer Skills (word, excel, powerpoint and Access)
• Excellent communication (both verbal and written) & interpersonal skills
• Flexible, highly motivated individual and accountable
• Knowledge and Experience of Statistical Process Control would be beneficial

To apply for this role please click apply now or email your CV to siobhan.morrissey@eflexes.com