6 Soft Skills Every Medical Device Auditor Needs

In the world of medical device compliance, auditors are often recognised for their technical expertise—deep knowledge of standards, regulations and products.

However, while regulatory understanding forms the backbone of effective auditing, soft skills are the connective tissue that determines whether an audit truly adds value.

Increasingly, organisations are discovering that the most successful auditors aren’t just technically proficient—they are excellent communicators, collaborators, and critical thinkers.

So in this article, I will go through the various soft skills that I believe are really important for auditors to possess in order to get the best results for themselves and their auditees.

I could really write a whole piece on each one of these or more.

1. Continuous Communication

It is all too often that communication about the status of the audit only occurs at the opening meeting.

In real medical device style, communication should occur throughout the lifecycle of the audit.

Auditors must ask precise questions, listen actively, and communicate findings in a way that is factual yet constructive.

This can be really dealt with by scheduling regular check-ins with key auditees throughout the audit where you create opportunities to brief auditees on the status of the audit as well as communicate potential findings, overdue records, and understand audit team availability etc.,

A lack of constant communication can often result in a lack of rapport being built with auditees and therefore make for a less collaborative and effective audit.

2. Empathy: Consider the Stress Levels of Auditees

Auditing can create stress for auditees, especially in regulated environments where nonconformities carry significant consequences, or where organisations have cultures that may not receive nonconformities as ways of looking for improvement.

A key way to spot if there is more pressure on auditees, especially with Management Representatives is when Quality Objectives are things such as "No findings in internal and external audits".

Auditors with high emotional intelligence:

• Read the room and adjust their approach

• Navigate tensions calmly and respectfully

• Foster a sense of partnership rather than interrogation

• Understand when the person receiving the finding is not really the owner of the finding

This not only smooths the audit process but also supports a culture of openness—essential for identifying true systemic issues.

3. Adaptability in Dynamic Environments

Audits rarely go exactly as planned. Documents are missing, process owners are unavailable, or unexpected risks emerge.

Adaptable auditors remain composed, adjust their audit trail as they go, and maintain alignment with audit objectives despite shifting circumstances.

This adaptability is especially important in complex regulatory frameworks such as MDSAP where interdependencies require flexibility and a broader perspective.

4. Diplomacy in Delivering Findings

How a nonconformity is delivered can determine whether an organisation embraces or resists the message.

I always believe a diplomatic auditor will call the finding potential and give the auditees an opportunity to demonstrate that conformity to the requirement being assessed.

Diplomatic auditors:

• Focus on objective evidence

• Provide context for the finding

• Communicate in neutral, supportive language

• Encourage a solutions-oriented mindset

This softer approach of identifying potential nonconformities first, and giving auditees ample opportunity to demonstrate conformity shows to the auditees that you are auditing for conformity, not nonconformity.

5. Time Management for Efficient, High-Quality Audits

If only the audit plan was spot on every time. However, in true Murphy’s law spirit, what can go wrong will go wrong.

Firstly, the audit plan should be designed in mind with things deviating from it ultimately.

A well-planned audit respects both the auditor’s and the organisation’s time. Strong time-management skills ensure:

• Efficient evidence gathering

• Proper prioritization

• Adherence to the audit plan

• Sufficient time for analysis and reporting

Well-managed audits reduce disruption and help teams stay focused on their core responsibilities.

However, that being said, people will be absent, traffic will happen, records will not be available immediately, lunch will (or won’t) arrive or WIFI could go down. Do you get my point? Anything can happen on an audit, and anything probably will happen, so auditors must be excellent at managing time to ensure the audit stays on track.

6. Integrity

I’ve put integrity last, but it is certainly not least. It is one of the 7 key principle of ISO 19011 - Guidelines for Auditing Management Systems.

I wanted to cement its importance by summarising previous points we’ve decided, such as constant communication, auditing for conformity not nonconformity, diplomacy and empathy.

Integrity is the foundation of an auditor’s credibility. It ensures that every conclusion is based solely on objective evidence—not assumptions, personal preferences, or external pressure. When auditors uphold integrity, they maintain independence, resist influence, and deliver findings that accurately reflect the true state of the system. This protects the organisation, supports regulatory compliance, and strengthens trust in the audit process.

A Balanced Skill Set Creates Better Audits

I really could write a whole piece on each one of these (I might). However, to conclude, regulatory and technical knowledge will always be essential, but soft skills determine how effectively that knowledge is applied. When auditors combine competence with communication, empathy, and integrity, audits become more transparent, collaborative, and impactful.

As the medical device industry continues to evolve—driven by more complex standards, increasing regulatory scrutiny, and automated systems—the importance of these human-centered skills will only continue to grow.