Quality Assurance Specialist ensuring compliance with quality standards in MedTech company. Collaborating with cross - functional teams and maintaining quality improvement processes.
About the role
- Quality Engineer ensuring product quality and compliance through product lifecycle at AirLife. Supporting cross-functional teams and driving risk analysis and continuous improvement efforts.
Responsibilities
- 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.
Benefits
- Health insurance
- 401(k) matching
- Flexible work hours
- Paid time off
- Remote work options
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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