The company seeks a Quality Assurance Engineer to ensure that new product designs and manufacturing processes meet all relevant safety and efficacy requirements.
About the Role
* Represent quality interests within project teams, leading quality engineering tasks and risk management activities such as UFMEA, DFMEA, PFMEA, and related documentation.
* Review design compliance, conduct statistical analyses (e.g., DOE), and initiate corrective actions when necessary.
* Support biocompatibility testing aligned with ISO10993, participate in internal and supplier audits, and validate test methods and measurement systems like Gauge R&R.
Requirements
* Third-level qualification in engineering, science, or a technical field.
* Minimum of five years' experience in the medical device or pharmaceutical industries.
* Familiarity with regulations including ISO 13485, CFR 11820, ISO 14971, and CMDR.
Benefits
* A competitive package of compensation and benefits programs.
* Opportunities for professional growth and development.
* A collaborative and inclusive work environment.
About You
* Strong problem-solving techniques and excellent organization skills.
* Excellent interpersonal skills and ability to work in a team environment.
* Dedication to excellence and flexibility.