Quality Engineer II
Job description
About the role
The establishes and maintains the structural elements of the quality management system to ensure our products achieve the highest possible standard of excellence in the market. This position is responsible for the oversight of verification and validation processes, ensuring that every product release meets the stringent requirements set forth by regulatory bodies and customer expectations. The role owner acts as a critical bridge between development and compliance, translating complex regulatory standards into actionable quality procedures for the team. You will analyze product performance data to identify deviations and drive corrective actions that prevent recurrence across the product lifecycle. This function requires a proactive approach to risk management, where potential quality issues are identified and mitigated before they impact customers or regulators. The Quality Engineer II will own the creation and maintenance of quality artifacts that prove adherence to standards and support continuous process improvement initiatives. Success in this role is defined by the ability to operate with autonomy while ensuring the integrity of the product and the quality system is never compromised.
Key facts
What you'll do
Investigate product performance data to uncover root causes of non-conformances and drive implementation of effective corrective actions.
Develop and execute validation protocols that confirm product designs meet predefined user needs and intended uses.
Perform gap analyses of existing processes against regulatory standards to identify areas for improvement and remediation.
Create and maintain traceability matrices that link requirements to design, verification, and validation activities.
Lead cross-functional reviews of design inputs and outputs to ensure completeness, accuracy, and compliance.
Execute testing procedures to verify that products meet all performance specifications prior to market release.
Analyze quality metrics and trends to support data-driven decisions for process optimization and risk mitigation.
Document quality procedures and work instructions to ensure consistency and clarity for all team members.
Collaborate with regulatory affairs to ensure all submissions and documentation align with current regulations and standards.
Support the development of quality objectives that align with business goals and regulatory compliance requirements.
Review audit findings and lead follow-up activities to close identified gaps and improve system effectiveness.
Serve as the subject matter expert for quality systems within the engineering organization, providing guidance and training.
Monitor industry updates and regulatory changes to ensure the quality system remains current and compliant.
Facilitate root cause analysis activities to prevent recurrence of quality issues and drive sustainable solutions.
Requirements
The posting states a bachelor's degree requirement. A degree is required for this role.
Five to seven years of relevant experience is required for this position.
Knowledge of applicable regulations and standards is required for compliance work.
Ability to work independently and exercise judgment to determine appropriate action is required.
Strong communication skills are required to implement quality objectives and collaborate with development teams.
Practical notes
Work is performed in a collaborative team environment and is subject to occasional travel. Work is performed in an onsite location at the specified office. Typical interview steps
Hiring for engineering roles usually starts with a recruiter screen, followed by one or two technical rounds. Candidates often solve a coding problem, discuss past projects, and answer system design questions. Some loops include a take-home task. Final rounds typically cover team fit and give candidates a chance to ask questions. Interviewers look for how you break down an unfamiliar problem, not just whether you reach the answer. Practicing a few problems aloud and reviewing your own past projects are the best preparation.
Practical notes
Work is performed in a collaborative team environment and is subject to occasional travel. Work is performed in an onsite location at the specified office.