About the Role

As a Quality Engineer at Inertia, you will play a pivotal role in ensuring product quality, regulatory compliance, and continuous improvement across the product lifecycle. You will act as a key partner to three core teams:

1. Product Strategy Teams Supporting the definition of quality requirements for both the product and the project.
2. Design & Development Teams Supporting DFMEA, Verification & Validation planning, and New Product Introduction (NPI).
3. Manufacturing Team Driving quality in production, addressing non-conformances, and leading 8D problem-solving.

The Service Delivery Team is made up of Product Strategy, Product Development, and Product Manufacturing, ensuring that Inertia delivers high-quality, compliant, and innovative medical devices while continuously improving its ISO 13485-certified Quality Management System (QMS).

What You Will Do

1. Support Product Strategy Teams

• Quality Requirements Definition: Collaborate with product strategy teams to define quality expectations, regulatory requirements, and project-specific quality goals.
• Product certification requirements: Determine
• Risk Management & Planning: Ensure that quality and compliance considerations are integrated from project inception.

2. Support Design & Development Teams

• Risk Management & Design Controls: Lead DFMEA development, ensuring risk mitigation is embedded in early design phases.
• Verification & Validation (V&V): Develop V&V plans, oversee test execution, and ensure compliance with regulatory requirements.
• New Product Introduction (NPI): Support first article inspections (FAI), develop control plans, and implement IQ/OQ/PQ protocols.
• Requirements Traceability: Ensure robust traceability between design inputs, risk analysis, and verification testing.
• Reliability Testing: Support Design for Reliability (DfR) efforts, including HALT/HASS and lifecycle testing.
• Regulatory Compliance: Ensure design and development processes comply with ISO 13485, FDA QSR (21 CFR Part 820), MDR, and other applicable regulations.

3. Support Serial Manufacturing Team

• Process Validation: Lead IQ/OQ/PQ for new and existing processes to ensure robustness in production.
• Non-Conformance Management (NCRs): Investigate and resolve non-conformances, drive root cause analysis (8D), and implement corrective actions.
• Corrective and Preventive Actions (CAPA): Lead CAPA investigations, ensuring issues are systematically resolved and prevented.
• Process Capability Studies (Cp, Cpk, Pp, Ppk): Analyze manufacturing variability and process stability.
• Measurement System Analysis (MSA): Conduct Gage R&R studies to ensure repeatable and reproducible inspection methods.
• Change Control Oversight: Participate in Engineering Change Orders (ECOs) to assess quality impact.
• Statistical Process Control (SPC): Implement real-time quality monitoring in production.
• Supplier Quality: Support supplier audits, manage supplier NCRs, and ensure incoming materials meet quality standards.

4. Develop and Improve Quality Systems for Service Delivery

• Process Improvement: refine quality processes for Product Strategy, Product Development, and Product Manufacturing.
• Standardization & Best Practices: Develop templates, tools, and procedures to ensure consistency and efficiency across projects.
• Receiving Inspection Plans: Develop sampling plans (AQL-based, ANSI Z1.4) for incoming materials.
• Supplier Risk Assessment: Evaluate suppliers based on performance, process capability, and risk factors.
• Supplier Corrective Actions (SCARs): Work directly with suppliers on incoming inspection, material review boards (MRB), and supplier corrective actions.
• Training & Compliance: Educate internal teams on quality processes, ensuring alignment with industry best practices.

5. Lean & Six Sigma in Quality Engineering

• Defect Pareto Analysis: Lead root cause deep dives using Pareto charts and data-driven prioritization.
• Continuous Improvement Events: Facilitate Kaizen or DMAIC projects focused on defect prevention.
• Waste Reduction in Quality Inspections: Optimize inspection frequencies and automate where possible.
• Operational Excellence: Implement Lean Six Sigma principles to improve efficiency and reduce defects.

6. Training & Knowledge Sharing

• Manufacturing Team Training: Teach operators about critical-to-quality (CTQ) characteristics, inspection techniques, and common failure modes.
• Quality Culture Development: Drive initiatives to instill a quality at the source mindset across teams.
• Mentoring Junior Engineers: Provide guidance on FMEA, CAPA, and regulatory compliance best practices.

What Success Looks Like in the First 6 Months

Fully integrated into Inertias QMS and capable of leading design reviews, supplier quality initiatives, and process validations.
Built strong working relationships with Product Strategy, Product Development, and Product Manufacturing teams.
Implemented key improvements in risk management, V&V execution, and manufacturing quality processes.
Identified opportunities for CAPA effectiveness and supplier quality improvement.

Who You Are

Required Qualifications

• Education: Bachelors degree in Mechanical, Electrical, Biomedical, or Manufacturing Engineering (or equivalent experience).
• Experience:
  • 5+ years in medical device quality engineering (ISO 13485 environment).
  • Strong background in design quality, risk management, and process validation.
  • Hands-on experience with DFMEA, PFMEA, V&V, IQ/OQ/PQ, CAPA, and 8D problem-solving.
  • Working knowledge of FDA QSR (21 CFR Part 820), MDR, ISO 14971 (Risk Management), and IEC 62304 (Software Lifecycle Process).
• Technical Skills:
  • Proficiency in Lean & Six Sigma methodologies for process improvement.
  • Experience with SPC, measurement system analysis (MSA), and DOE.
  • Strong knowledge of root cause analysis techniques (8D, 5-Whys, Ishikawa, etc.).

Preferred Qualifications

• Experience building and auditing quality system.
• Experience with electronic assembly quality control in medical device manufacturing.
• Familiarity with statistical software (Minitab, JMP) and quality tools (JIRA, SharePoint, PLM systems, etc.).
• Green Belt or Black Belt in Lean Six Sigma.

Why Join Inertia?

At Inertia, youll be more than a Quality Engineeryoull be a key driver of innovation and excellence in medical device development and manufacturing. We foster an open, collaborative culture where engineers, designers, and manufacturing professionals work together to deliver world-class products.

Growth & Impact Shape quality processes that impact cutting-edge medical devices.
Cross-Functional Leadership Work across Product Strategy, Product Development, and Product Manufacturing teams.
Top-Tier Team Be part of a talented and mission-driven engineering culture.
Certified Great Place to Work Join a team recognized for its outstanding workplace culture.