Job Description:
We are seeking a highly skilled Quality Assurance Engineer to join our team in ensuring the highest-quality and most competitive products and services reach our customers and their patients.
About the Role:
In this role, you will be responsible for representing quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation. You will review design compliance, conduct statistical analyses (e.g., DOE), and initiate corrective actions when necessary. Your responsibilities will also include supporting biocompatibility testing aligned with ISO10993, participating in internal and supplier audits, and validating test methods and measurement systems like Gauge R&R.
Key Responsibilities:
* Represent quality interests and concerns on project teams.
* Lead risk management activities and own the Quality engineering activities for NPD projects.
* Review design control compliance requirements for NPD projects and all design elements.
* Develop and coordinate UFMEA & DFMEA, supporting the development of PFMEA.
* Perform DOE's and other statistical analysis to support product and process optimization or resolve causes of process variation.
* Initiate corrective actions as required.
* Support assessment of Biocompatibility testing required as per ISO10993 and company procedures.
* Participate in internal audit and supplier audit programmes.
About You:
To be successful in this role, you should possess a third-level qualification in engineering, science, or a technical field, along with a minimum of five years of experience in the medical device or pharmaceutical industries. A solid understanding of regulatory standards, including ISO 13485, ISO 14971, and related CFRs, is essential. Preferred skills include attention to detail, adaptability, strong problem-solving abilities, and excellent interpersonal skills. The role requires someone who can manage multiple projects independently while collaborating effectively in team settings and meeting deadlines consistently.
Benefits:
Our company offers a culture in which you can learn, grow and thrive. You will have the opportunity to help shape the trajectory of our company while leaving a legacy at the same time. We welcome people with the imagination and drive to help us reinvent the future of health.