AETHER Quality Intrapreneurship

"Quality means doing it right when no one is looking." - Henri Ford

Quality Project Management Roles

Quality is a key objective in Intrapreneurial Projects. Engineering organizations need robust quality systems that support innovation while ensuring regulatory compliance, and without crossing the line of unecessary over-quality.
Our right-hand Quality project managers offer assistance tailored to your unique challenges.

Apply spontaneously to stay in the loop of Quality-related events and opportunities in your district.

QMS & Regulatory Project Manager

We focus on regulatory compliance to ensure business continuity. 

Quality Assurance Project Manager

We focus on specifications compliance  to ensure client satisfaction.

Operational Quality Project Manager

We focus on preventive and corrective actions to minimize losses.

Quality Assurance, Validation & Control 

Project Quality Assurance

  • QA Project Lifecycle – Provide technical guidance on quality requirements throughout project lifecycles.
  • QA Metrics – Track KPIs and quality metrics to drive performance.
  • QA Plans – Develop, document, and implement QA policies, procedures, and Quality Assurance Plans (QAP).

Process Validation and Quality Control

  • Process Validation – Define and execute validation protocols for manufacturing processes.
  • Process Validation Analysis – Review test results, perform statistical analysis, and document findings in validation reports.
  • Process Validation Follow-up – Ensure processes remain in a validated state, perform periodic requalification, and implement improvements based on deviations or change control.
  • Validation Documentation – Document validation activities in compliance with regulatory and quality requirements.
  • Define QC Methods – Define and maintain product specifications with standard quality testing methods.
  • QC Tests – Perform analytical and physical testing on incoming materials, intermediates, and finished products: Dimensional & Visual, Functional, NDT (Non-Destructive), Chemical/Analytical, Electrical, Software, Environmental/Stress.
  • QC Equipment Calibration – Maintain calibrated quality control equipment to ensure measurement accuracy.
  • QC Laboratories – Use accredited external laboratories for specialized or regulated QC tests.
  • QC Reports – Prepare clear QC reports detailing methods, results, deviations, and conclusions.
  • Product QC Before Release – Ensure product conformity to quality specifications before release.
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Customer, Stakeholder & Training Management

  • Customer Complaints – Manage customer complaints and coordinate resolution.
  • QA Stakeholders Interface – Act as the quality interface for internal and external stakeholders, supporting project managers.
  • Subcontractor Qualification – Support qualification and performance monitoring of subcontractors.
  • Quality System Training – Deliver training on ISO/GMP and quality best practices.
  • Operational Quality Training Creation – Develop and deliver training materials on operational quality practices.
“"Quality means doing it right when no one is looking."
Henry Ford

Compliance & Audit Management

  • Unannounced Inspection Readiness – Maintain readiness for unannounced inspections by implementing procedures, records, and controls that demonstrate compliance at any moment.
  • Quality Audits – Plan and conduct internal and external customer, project, and product quality assurance audits to verify conformance to standards and client requirements.
  • Regulatory Monitoring – Continuously monitor regulatory changes, assess operational impact, and coordinate necessary adaptations.
  • Standards Conformity – Ensure conformity with ISO, GMP, CE, or other sector-specific standards by aligning processes and documentation.
  • Regulatory Liaison – Act as liaison with regulatory bodies and certification authorities to manage inspections, certifications, and approvals.
  • Standards to Procedures – Translate standard requirements into practical, actionable procedures for the organization.

CAPA Deficiencies Are a Top FDA Observation in MedTech

During FDA inspections, CAPA system deficiencies are among the most frequent Form 483 observations in the medical technology sector. The most common gaps include:
  • Missing or incomplete documented CAPA procedures
  • Superficial root cause investigations
  • No effective verification of action effectiveness

The 1-10-100 Quality Rule Applied to CAPA

In life sciences quality management, it’s established that $1 spent on prevention equals $10 for product control and $100 for correcting a product failure. A well-designed CAPA system—especially preventive actions—delivers far higher ROI than corrective fixes after an incident.

Corrective & Preventive Action (CAPA) Systems

  • QA Deviation Detection – Inspect products and processes to detect deviations from standards and document audit findings.
  • QC Deviation Investigation – Investigate out-of-specification results from QC tests and coordinate resolution.
  • CAPA Implementation – Implement CAPA and risk management systems to address non-conformities and prevent recurrence.
  • CAPA Investigation – Investigate quality issues, identify root causes, and implement corrective/preventive actions.
  • CAPA Tracking – Track and verify the effectiveness of corrective measures over time.

Operational Quality &  Continuous Improvement

  • Culture of Continuous Quality Improvement – Promote and embed a culture of quality continuous improvement across the organization.
  • QA Lessons Learned – Facilitate lessons learned and best practice sharing across teams.
  • QMS Improvement – Drive QMS optimization for efficiency and compliance.
  • Quality Data Analysis – Analyze quality data to detect trends and improvement opportunities.
  • Operational Quality Guidance – Provide ongoing guidance to ensure awareness and compliance with operational quality.
  • Quality Improvement – Lead initiatives to enhance product quality and process efficiency.
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