Sr. Quality Assurance Engineer

· Works with R&D and Manufacturing Engineers to support implementation of new products by developing quality and testing plans. Supports the new product development process as a team member. Answers any questions or concerns with device quality / reliability within the new product development team.

· Participates in establishing and reviewing specifications/requirements for components, products and processes as part of new product development. Provides feedback on manufacturing-related documentation for regulatory submissions and product release.

· Participates in teams responsible for the procurement and installation, operational and performance qualification (IQ/OQ/PQ) of manufacturing equipment/processes.

· Develops Quality Plans for quality systems that adhere to the QMS.

· Leads and participates in quality metrics reviews; identifying weaknesses and risks associated with MicroAire products and tracking the mitigation of those issues throughout the corrective action process.

· Works with Suppliers to maintain high quality levels of incoming production materials. Supports Supplier Quality by providing reliability input in the evaluation of discrepant material and in the qualification of new material to assure that device reliability

are met. Participates in quality audits of suppliers.

· Partners with cross-functional departments as required, mentoring and aiding teams in performing complaint investigations and CAPA activities.

· Partners with suppliers and supply chain as required to improve quality, cost, and delivery from suppliers. Works with incoming inspection to ensure adequate and robust quality inspections. Performs gauge R&R, capability analysis, etc as required.

· Utilizes standard statistical analysis and problem-solving techniques as necessary to determine product acceptance limits, establish process parameters, resolve quality problems, etc.

· Supports quality system maintenance by identifying and correcting deficiencies in procedures and practices.

· Leads and supports CAPA teams in the analysis and resolution of product quality issues.

· Leads and implements QMS software solutions aimed at continuously improving the QMS.

· Performs other job-related duties and activities as assigned.

· Six years of Quality or Manufacturing Engineering experience required, supplier quality engineer experience preferred

· Medical device experience is highly desirable; regulated industry experience required

· Fabrication, machining, and assembly knowledge and experience of mechanical and electrical assemblies are highly desirable

· Lean-Six-Sigma experience preferred.

· American Society for Quality, Certified Quality Engineer (CQE) preferred.

+ Competencies

Competency

Skills

Behaviors

Quality Systems & Regulatory Compliance-

Demonstrates deep knowledge of Quality Management Systems (QMS), regulatory requirements, and quality engineering principles to ensure products, processes, and systems consistently meet customer, company, and regulatory expectations.

• ✓QMS management
• ✓FDA, ISO 13485, and regulatory compliance
• ✓CAPA systems
• ✓Internal and external auditing
• ✓Documentation and change control
• ✓Design controls
• ✓Ensures compliance

are integrated into daily activities.

• ✓Proactively identifies and addresses quality system gaps.
• ✓Maintains accurate and audit-ready documentation.
• ✓Demonstrates strong attention to detail and regulatory discipline.

Risk Management & Problem Solving-

Uses data, risk-based thinking, and structured problem-solving methodologies to identify, assess, and mitigate product, process, and system risks while driving sustainable corrective actions.

• ✓Risk analysis (FMEA, Risk Management Reports)
• ✓Root cause analysis
• ✓Statistical analysis
• ✓CAPA leadership
• ✓Data interpretation
• ✓Corrective and preventive actions
• ✓Prioritizes actions based on risk and business impact.
• ✓Identifies root causes rather than treating symptoms.
• ✓Uses data to make objective decisions.
• ✓Drives timely resolution of quality issues and prevents recurrence

Technical Quality Engineering Expertise-

Applies engineering knowledge and quality methodologies throughout product development and manufacturing to ensure products are safe, effective, reliable, and manufacturable.

• ✓Validation protocols (IQ/OQ/PQ)
• ✓Design verification and validation
• ✓Process qualification
• ✓Supplier quality engineering
• ✓Reliability engineering
• ✓Test method development
• ✓Provides