Job Title: Quality Assurance Specialist
Our organization is seeking a skilled and detail-oriented Quality Assurance Specialist to ensure the highest quality standards in our new brand identity.
This role combines hands-on quality engineering with strategic influence, embedding excellence into every stage of the rebrand process.
Key Responsibilities:
* Act as the voice of quality during a major brand transition, ensuring processes, documentation, and systems align with the refreshed identity.
* Lead process improvement and cost optimization projects using statistical tools such as Design of Experiments (DOE), sampling plans, and root cause analysis.
* Own and guide change controls, risk assessments, and process validations linked to rebrand-driven changes.
* Manage Corrective Action Preventive Action (CAPA) reports, non-conformances, Special Cause Analysis Reports (SCARs), and supplier quality activities to maintain product and process integrity.
* Conduct internal and supplier audits and support regulatory inspections.
* Oversee updates to manufacturing, packaging, and labeling processes to reflect the new brand identity while ensuring full compliance.
* Develop and track Key Performance Indicators (KPIs) to measure quality performance during and after the rebrand.
Requirements:
* Degree in Engineering, Science, or a related discipline.
* Minimum 3 years' experience in a regulated manufacturing environment, preferably medical devices or FDA/ISO 13485-certified industries.
* Strong working knowledge of quality tools (FMEA, DOE, root cause analysis, statistical analysis).
* Excellent attention to detail with proven problem-solving ability.
* Strong communication skills, with the ability to explain technical concepts to non-technical audiences.
* Proficient in MS Office applications (Excel, Word, PowerPoint).