Responsibilities may include the following and other duties may be assigned:
Assist in aligning and implementing design control processes, including requirements management, design reviews, verification/validation, and traceability.
Support the mapping, migration, and harmonization of quality system processes, including document control, training, audits, and related quality activities; support internal and external audits as applicable.
Participate in the integration and standardization of CAPA and complaints handling processes, ensuring effective root cause analysis, corrective and preventive actions.
Support software development lifecycle processes, including requirements management, design reviews, validation, and testing.
Ensure all integrated processes meet applicable regulatory requirements (FDA, MDR, ISO 13485, 21 CFR Part 11, etc.), including electronic records and signatures, risk analysis, and audit readiness.
Assist in updating and maintaining quality documentation, provide training to stakeholders on new or revised processes, identify process gaps, and support continuous improvement initiatives.
Required Knowledge and Experience:
Bachelors degree in Engineering, Life Sciences, or a related field.
3+ years of experience in medical device quality engineering, including QMS, design controls, CAPA, complaints management, and software validation.
Working knowledge of FDA regulations, MDR, ISO 13485, and 21 CFR Part 11 requirements.
Experience with software development lifecycle processes in regulated environments is an advantage.
Strong analytical, communication, and teamwork skills, with the ability to work effectively in cross-functional environments.
Experience with QMS integration or harmonization projects and electronic QMS platforms would be considered an advantage.
Physical Job Requirements:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
