Our organization is seeking a highly skilled Senior Quality Engineer to join our team. This individual will be responsible for ensuring the quality of our products and processes, and will work closely with design teams to provide assurance support according to international regulatory requirements.
Job Description:
* Ensure proprietary design & development projects are executed in compliance with relevant regulations, regulatory requirements, international standards, and enterprise and local procedures.
* Identify and support the use of improved quality practices by R&D teams during design control activities; and facilitate the smooth integration of quality requirements into design processes.
* Report on the progress of projects; identify successes; and drive compliance.
* Escalate quality-related issues to the Design & Quality Assurance Director or designee, as required.
Requirements:
* Bachelor's Degree in Chemistry, Engineering, or Quality discipline required.
* 5 years working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sectors.
* Desirable: Regulatory Affairs experience.
* Working knowledge of ISO 13485, ISO 9001, ISO 15378, and 21 CFR Part 820 essential.
Benefits:
We offer a competitive salary and benefits package, including a strong culture of compliance and continuous improvement. Our team members enjoy opportunities for lifelong learning, growth, and development, supported by benefit programs that empower their physical, mental, emotional, and financial health.
Additional Requirements:
1. Exhibit a strong