Quality Engineer

At AliveDx, we empower diagnostic insights, transform patient care, and innovate for life. With over 30-years in in-vitro diagnostics, we put the health of patients first by creating innovative solutions designed for faster diagnostic results. Alba–– our blood bank reagents portfolio–– and MosaiQ®–– one of the first multiplexing and multimodality automated testing platforms––are designed to make labs more efficient and clinical decision-making more effective. Our journey started as Alba Bioscience, and later, Quotient. Today, as AliveDx, we innovate for life.

QUALITY ENGINEER

AliveDx is recruiting for a Quality Engineer to join the Quality team based in Penicuik, Scotland.   The Quality Systems Department is a part of the wider Quality group at Alba Bioscience, part of AliveDx, and its primary role is to ensure that all aspects of Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) compliance are met through effective control of the Quality Management System (QMS).

The role is a full-time temporary position working flexible working hours.

YOUR MISSION

The Quality Engineer is responsible for assisting in the maintenance of the quality management system and the records therein. They should look to maintain collaborative relationships with colleagues from all areas of the business and ensure ongoing quality improvement while maintaining compliance with internal procedures and the required standards.

Your main responsibilities will include:

• Has Working Knowledge of Quality Management System Concepts and Procedures; performs a variety of routine tasks or assignments.
  • Non-Conformance assessment and progression
  • Change Control assessment and progression.
  • Quality Meeting facilitation

• Follows prescribed guidelines or procedures to provide solutions to problems.
  • Root Cause Analysis.
  • Trend quality data from key data (e.g. non-conformance, CA/PA)

• Works with moderate level of guidance
  • Ownership of Issues
  • Internal auditing

• Continues to build knowledge of the business, processes and customers (internal and external)
  • Assist during internal/external audits from customers and regulatory bodies.
  • Compile and contribute to quality metrics and trending accordingly to her activities.
  • Identify areas for improvement and contribute to a culture of continuous improvement.
  • Demonstrate and exhibit all key behaviours as defined by the business.
  • Participate in an 'in-house' programme of continuous training and assessment.

• Conduct all duties in compliance with Good Manufacturing Practice (GMP), Good Documentation Practice (GDP) and appropriate regulatory requirements including statutory Health & Safety legislation and internal practice.

• Perform any other duties as reasonably requested from the Company from time to time.

YOUR COMPETENCIES

• A relevant degree and/or relevant work experience.
• Experience at an appropriate level in the Quality function of a business operating to cGMP.
• Good understanding of core IT packages, especially Microsoft Excel
• Clear communication in spoken and written form.
• Effective time management and prioritisation skills.
• Proactive and able to work effectively independently or within a team, participating in R&D project teams as required and delivering end results under tight timelines.
• Great attention to detail with a thorough and methodical approach to work.
• Ability to analyse situations and processes to eliminate problems.
• Ability to work under pressure of a high workload, meet deadlines and respond flexibly High sense of responsibility and accountability to ensure compliance and to inspire colleagues to do the same.

WHAT WE OFFER

• A highly dynamic and growing environment.
• An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do.
• A flexible working environment where applicable as well as a range of core additional benefits ranging from lunch allowance support, annual leave, mobility and access to marketplace discounts.

Interested? We look forward to receiving your application.

AliveDx is an equal opportunity employer and welcomes applications from all qualified individuals regardless of nationality, sex, disability, region/belief, sexual orientation or age. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on competences, performance and business needs.