The Quality Engineer position is focused on ensuring product quality and compliance through the entire product lifecycle, from design through post-market activities.
This position supports cross-functional teams including Purchasing, Suppliers, Incoming Inspection, Production, Engineering, and Customers through a strong focus on verification and validation activities to ensure product meets its performance, functionality and intended use requirements.
This position leads and supports risk analysis activities to effectively implement risk mitigations and control measures in accordance with applicable standards.
Additionally, this position interprets, defines, and develops product quality requirements and ensures testing meets all quality standards.
It is also responsible for identifying, analyzing, troubleshooting, and resolving non-conformance issues.
In addition, this position will drive continuous improvement in quality processes.
Requirements
2+ years of experience in Quality is highly preferred.
Understanding and experience in AQL inspection, control plans and interpretation of spec and drawings.
Design Controls and Risk Management: Experience in product verification and validation, test method validation, Statistics, Risk Management Tools ISO 13485.
Corrective Action and Preventative Action.
Root Cause Analysis.
Complaint Handling / Post Market Feedback.
Basic understanding of mechanical engineering concepts.
Ability to analyze defective products.
Strong decision-making abilities.
Demonstrated technical writing skills.
Proven ability to work across organizational functions.
Strong ability to multi-task and to manage time.
Strong interpersonal skills, including effective verbal and written communication.
Ability to interact effectively with functions of a global organization to achieve goals.
Demonstrated ability in prioritizing and completing projects with cross-functional teams.
Thorough understanding of quality control standards and methodologies.
Analytical problem-solving skills.
Demonstrated objectivity and KPI driven acumen.
Proficient with Microsoft Office Suite or related software.