Senior Quality Engineer
We seek an exceptional Senior Quality Engineer to spearhead the development and sustaining of innovative products, ensuring they meet stringent quality and compliance standards.
* Oversees design controls, risk management, and change control processes, guaranteeing seamless project execution.
* Leads comprehensive risk management activities, manages Design History File (DHF) documentation, and fosters a culture of accountability.
* Supports strategic compliance initiatives, reviews verification and validation plans, and collaborates with cross-functional teams.
* Challenges statistical rationales, authorizes deviations, and ensures alignment with organizational objectives.
* Assists in failure investigations, tracks software issues, and drives process improvements.
* Advocates a strong quality culture within project core teams, promoting a proactive approach to quality assurance.
Responsibilities:
* Design Assurance Quality Engineer on project core teams, driving quality excellence.
* Develops and maintains DHF documentation, ensuring accuracy and completeness.
* Manages risk and compliance activities, minimizing project risks.
* Coordinates verification and validation efforts, guaranteeing product conformity.
* Reviews testing procedures and documentation, ensuring adherence to industry standards.
* Analyzes statistical rationales and data, informing informed decisions.
* Authorizes deviations, balancing business needs with quality requirements.
* Investigates failures and conducts problem-solving sessions, fostering a culture of continuous improvement.
* Tracks software issues, driving swift resolution and customer satisfaction.