Senior Quality Engineer – Boston Scientific
Join to apply for the Senior Quality Engineer role at Boston Scientific located at our Clonmel facility, supporting production lines and new product implementation within the Scopes Urology portfolio.
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 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.
* 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.
* Identify and control manufacturing‑related process defects 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.
* Coordinate and conduct technical investigations of non‑conforming events using eCAPA and BSC Engineering Essentials.
* Lead investigations into internal and external customer complaints and 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.
About Boston Scientific
As a leader in medical science for more than 40 years, Boston Scientific is committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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