Senior Quality Engineer

Senior Quality Engineer

Dynamic Senior Quality Engineering role supporting all aspects of line support for existing production lines and new product implementation within the Scopes Urology portfolio at our Clonmel facility. This position offers a significant opportunity to gain in-depth knowledge of the BSC Quality System, particularly Production and Process Controls and CAPA. The successful candidate will ensure delivery of the highest quality products to customers through robust process control, compliance, and continuous improvement initiatives.

Key Responsibilities:

• Develop an in-depth understanding of the manufacturing process for Urology Scopes products, including all aspects of production and process controls.
• Develop and/or review Process Qualifications, Test Method Validations, Gage R&R studies, Process Capability studies, Design of Experiments (DOE), and production control plans.
• Lead and own change-related activities in support of new product implementation, including establishing site-specific systems and controls.

Compliance & Audits:

• Lead back-room activities and provide front-room support during external audits, ensuring the production unit remains audit-ready at all times.
• Ensure regulatory compliance in all projects by applying quality tools and processes.

Continuous Improvement:

• Identify and control manufacturing-related process defects (scrap, non-conforming material, customer complaints) by leading root cause investigations and implementing corrective and preventive actions.
• Drive process improvement initiatives by capturing quality metrics and performing data analysis to enhance product design and development.

Leadership & Communication:

• Coordinate and conduct technical investigations of non-conforming events using eCAPA and BSC Engineering Essentials.
• Lead investigations into internal and external customer complaints.
• Provide clear communication to stakeholders during key technical updates.
• Mentor and guide less experienced staff as required.

Knowledge & Skills:

• Strong working knowledge of Quality Systems, particularly Production and Process Controls, Process Acceptance Activities, Non-conforming product controls, and CAPA.
• Proficient in problem-solving and process improvement methodologies (e.g., Engineering Essentials).
• Ability to plan, organise, and prioritise workload to meet deadlines.
• Strong interpersonal skills to influence peers and management.

Qualification Requirements:

• Level 8 honours degree in Engineering, Quality, or Science.
• Minimum 5 years' experience in a medical device or related regulated industry.
• Demonstrated leadership and communication skills.
• Preferred: Experience with eCAPA systems, BSC Engineering Essentials, and certifications such as Six Sigma or Lean.