Quality Engineer

Job Title: Senior Quality Engineer

Location: Galway, Ireland (Hybrid)

Department: Operations

Reports to: VP of Operations

Type: Full-time, Permanent

About Bluedrop Medical

Bluedrop Medical is a fast-growing medtech company developing sensor-based technology to prevent diabetic foot ulcers—a leading cause of amputation worldwide. Our advanced imaging and sensor platform enables earlier detection of complications, supporting clinicians in delivering better outcomes for patients.

Job Description -Senior Quality Engineer

Position Summary

The Senior Quality Engineer will provide operations quality leadership to support the commercialisation of a new medical device product, verification & validation, manufacturing ramp, product release, and post-market surveillance support. Essentially, ensure compliance to all aspects of our Quality Management System, as product is commercialised and production is ramped to maturity with our contract manufacturing partner.

Key Responsibilities

• Ensure compliance with FDA QSR (21 CFR Part 820), ISO 13485, ISO 14971, MDR, and other applicable regulations/standards, as product is commercialised and globalised across various markets.
• Lead operations quality engineering support for new product introduction, including Risk Management, Verification & Validation, Production & Process Controls, Equipment & Facility Controls, Manufacturing Records, Material Controls, Corrective & Preventive Actions [CAPA], etc.
• Develop, implement, and maintain process validation (IQ/OQ/PQ), equipment qualification, and test method validation, in partnership with our contract manufacturer.
• Understand risk management concepts used throughout the quality system to successfully meet FDA, ANSI/AAMI/ISO 14971:2019, and ANSI/AAMI/ISO 13485:2016 requirements.
• Drive operations & supply chain related CAPA investigations, root cause analysis, and implementation of effective corrective and preventive actions.
• Support supplier quality management, including supplier qualification, audits, and quality performance monitoring.
• Participate in internal and external audits (FDA, Notified Bodies, ISO, MDSAP).
• Lead efforts in operations related non-conformance investigations, disposition decisions, and statistical data analysis to identify trends and systemic issues.
• Develop and maintain quality metrics dashboards and contribute to Management Reviews.
• Support continuous improvement initiatives to enhance compliance, efficiency, product quality and cost-out activities.
• Work closely with cross-functional teams (R&D, Engineering, Software Engineering, Manufacturing, Supplier, Regulatory Affairs, etc.) to provide input on project decisions with a quality-first / compliance mindset.
• Perform product, process and quality trending using QMS data for product/process improvement efforts.
• Create, revise, and approve departmental procedures, work instructions and specifications.
• Assess operations [manufacturing contractor, raw material suppliers, etc.] to ensure adequate quality system controls are effective and resolve quality issues as they arise.
• Proactively investigate, identify, and implement best-in-class Operations Quality practices.

Qualifications & Skills

• Bachelor's degree in Engineering, Life Sciences, or related technical field.
• Minimum 5–8 years of quality engineering experience in the medical device industry.
• Proven New Product Development Quality & Post Market Quality experience with depth of knowledge in Operations functions.
• Strong knowledge of FDA QSR, ISO 13485 and EU MDR requirements.
• Hands-on experience with design controls, process validation, production controls, risk management, CAPA, and supplier quality.
• Proficiency with statistical analysis tools (Minitab or equivalent) and quality tools such as FMEA, SPC, DOE, and Root Cause Analysis.
• Demonstrated ability to lead cross-functional projects and influence decision-making.
• Strong problem-solving and analytical skills. Attention to detail with a compliance-driven mindset.
• Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving product quality issues and product /process improvement activities.
• Exhibit a strong "quality first" mentality and ensure that product quality is held to the highest standard.

What We Offer

• A mission-driven company committed to improving lives through innovative medical technology.
• A collaborative, flexible work environment in a dynamic medtech startup.
• Opportunities for career growth, ownership, and cross-functional impact.
• Competitive salary and comprehensive benefits package