Stryker - Axiscades E&T Limited

In regulated industries like medical devices, quality is not just a support function it's a strategic pillar. With increasing global scrutiny, shifting regulatory expectations, and the rapid pace of innovation, the role of a quality professional has evolved far beyond compliance. It now demands leadership in decision-making, technical problem solving, risk mitigation, and continuous improvement across the product lifecycle.

During my time in a high-impact quality operations role, I worked under minimal supervision, taking end-to-end ownership of critical quality activities in manufacturing, product transfers, and compliance assurance. Below is an in-depth overview of my responsibilities and the value I brought to the organization.

1. Partnering with Operations to Embed Quality in Every Step

My primary focus was to ensure that product quality and process robustness were embedded in operations. I collaborated cross-functionally with production, engineering, and business teams to monitor, improve, and sustain process performance.

This involved proactively analysing manufacturing trends, participating in shop-floor issue resolution, and helping teams understand how product requirements, regulatory expectations, and customer needs align.

2. Leadership in NC, CAPA, and Root Cause Analysis

I served as a mentor and approver for Non-Conformances (NCs) and Corrective and Preventive Actions (CAPAs), often taking the lead in complex problem-solving cases. My approach combined tools such as:

• 8D Methodology

• 5 Whys and Fishbone Analysis

• Process Mapping and Fault Tree Analysis

As a high-level contributor in these activities, I not only addressed individual failures but also uncovered systemic gaps, ensuring long-term corrective strategies were in place.

3. Manufacturing Process Improvement & Change Control

One of the core aspects of my role was to lead and support improvements to both existing and new manufacturing processes. This included:

Driving process validations (IQ, OQ, PQ) for new production lines or technology introductions

Supporting manufacturing transfers to other global sites

Reviewing and approving change control documents, challenging their effectiveness and encouraging robust impact assessments

In each case, my goal was to balance regulatory compliance with operational efficiency, ensuring that any changes strengthened rather than compromised process capability.

4. Expert in Risk Management & Human Factors Integration

I acted as a Subject Matter Expert in risk management, using tools such as:

FMEA (Design and Process)

Hazard Analysis

Fault Tree Analysis

I provided input into product risk files and facilitated cross-functional sessions to identify, assess, and mitigate risks in both new and legacy processes.

Additionally, I championed the integration of Human Factors Engineering (HFE) into quality investigations. By understanding how human interaction with devices or processes can introduce variability or error, I was able to recommend practical, design-centered mitigations that supported safer outcomes.

5. Quality Metrics, Data-Driven Decisions, and Continuous Improvement

Using quality metrics and Key Performance Indicators (KPIs), I regularly assessed trends in process performance, defect rates, and audit outcomes. This helped me take pre-emptive actions and recommend targeted continuous improvement projects.

I applied Lean and Six Sigma techniques to reduce waste, enhance inspection effectiveness, and drive first-time yield improvements. My ability to interpret statistical data, like control charts, Cp/Cpk values, and process trend analyses—helped steer the site toward data-informed decisions.

6. Driving Audit Readiness and Regulatory Engagement

I played an active role in internal and external audits, often acting as a spokesperson for quality processes.

This includes:

• Leading the preparation of audit documentation and logistics

• Presenting NC/CAPA systems, validation files, and inspection strategies

• Representing quality in discussions with Notified Bodies and regulatory authorities

• My comfort with regulatory language, combined with hands-on process knowledge, made me a reliable and confident interface during inspections.

7. Validation and Project Transfers

I was certified in validation and took responsibility for developing and reviewing validation strategies for new processes, packaging lines, and inspection technologies.

In global project transfer scenarios, I led quality activities, ranging from documentation readiness and equipment qualification to risk assessment and stakeholder coordination, ensuring flawless knowledge handover and compliance continuity across sites.

8. Empowering the Quality Voice in Cross-Functional Teams

Throughout my role, I consistently took the lead in cross-functional meetings, advocating for the voice of quality. I ensured that decisions made during design reviews, production escalations, and cost-saving initiatives did not compromise product safety or regulatory requirements.

I believe the quality function should act not just as a checkpoint, but as a partner in performance, guiding teams toward better, more resilient processes.

Skills and Tools I Applied

• Standards & Regulations: ISO 13485, ISO 14971, 21 CFR Part 820, GMP, GDP

• Quality Tools: FMEA, CAPA, RCA, MSA, Control Plans, Process Capability

• Systems & Platforms: SAP, TrackWise, MasterControl, Power BI, Excel (Advanced)

• Validation & Transfer: IQ/OQ/PQ, risk-based sampling, statistical techniques

• Soft Skills: Project leadership, stakeholder communication, training delivery

Conclusion

In this role, I was trusted to lead high-impact quality initiatives that required not just technical knowledge but also strategic thinking, team collaboration, and the ability to influence without authority. Whether it was resolving a product hold, defending a CAPA in an audit, or designing a more robust validation strategy, I approached each responsibility with ownership and precision.

As medical device regulations become more stringent and manufacturing complexity continues to grow, the need for quality professionals who can think holistically, across people, processes, and data, is more important than ever.