🚀 We’re hiring: Quality Engineer (NPI / R&D)
Are you passionate about building quality into innovative high-tech products from day one? We’re looking for a Quality Engineer who thrives in a fast-paced R&D environment and isn’t afraid to challenge the status quo.
Role Overview
We are looking for a Senior or Expert-level QA Manager with strong experience in product development, design reviews, prototype validation, and close collaboration with R&D and engineering teams.
The ideal consultant has deep technical affinity and is able to challenge mechanical, electronic, hardware and/or software engineering decisions, ensuring product quality from early concept through NPI and release.
This role is positioned at the intersection of R&D, Engineering, and Quality, requiring a hands-on and highly analytical professional who can act as a Quality delegate throughout the NPI lifecycle.
Key Responsibilities
1. Quality Leadership in Product Development
Act as Quality delegate in design reviews, early feasibility assessments, and product development meetings.
Perform technical challenge on engineering decisions related to mechanical, electronic, hardware and software components.
Ensure product quality requirements are integrated into design outputs and engineering documentation.
2. Prototype Verification & Validation
Participate in and review prototype validation, including functional, mechanical, electrical, and/or software testing activities.
Ensure that verification and validation (V&V) plans, test protocols, and test reports meet quality and compliance expectations.
Confirm that engineering teams execute V&V activities before design freeze or release.
3. NPI (New Product Introduction) & Stage Gate Quality
Act as Quality gatekeeper during NPI stage gate review meetings.
Ensure design robustness, risk mitigation (e.g., DFMEA/PFMEA), and test coverage before passing gates.
Support readiness for manufacturing transfer and release.
4. Quality Control & Release Authority
Monitor and report product and process performance metrics, deviations, and quality risks.
Hold authority to:
withdraw non?conforming products
place or release production/delivery holds
review and sign off Certificates of Conformity (CoC) beyond standard manufacturing CoCs
approve derogations where justified
5. CAPA & Continuous Improvement
Lead and facilitate root cause investigations and corrective actions (CAPA), focusing on technical/product-related issues.
Drive improvement initiatives for design processes, development workflows, and engineering practices.
6. Engineering Collaboration & Technical Problem-Solving
Work closely with R&D, Mechanical, Electrical, Hardware, and Software Engineering teams.
Challenge assumptions, technical decisions, and design alternatives with a quality and risk-based mindset.
Support structured troubleshooting activities and technical escalations.
7. Agile / Software-Related Quality
In Agile software projects, collaborate with Product Owners on:
roadmap planning
sprint planning
sprint reviews
prioritization of issues, risks, and opportunities
Provide QA inputs for software release decisions, ensuring V&V activities are completed before deployment.
8. Escalation & Customer Quality Support
Coordinate customer escalations and lead QA-related discussions with internal stakeholders.
Support customer complaint investigations related to product design or product performance.
Required Experience & Profile
Must-Have Skills
Senior-level experience in design review, product development quality, or R&D quality engineering.
Demonstrated experience working with mechanical, electronic, hardware and/or software engineers.
Proven ability to validate prototypes and review technical test documentation.
Strong analytical capability and confidence in challenging technical decisions.
Expertise in NPI processes and Quality gatekeeping.
Solid experience in CAPA, root cause analysis, deviations, and technical quality escalations.
Nice-to-Have
Experience with systems engineering, embedded software, or complex mechatronic products.
Familiarity with Agile/Scrum environments.
Knowledge of engineering documentation tools (e.g. Jira, Confluence, PLM systems).
Not required
Pharma experience (explicitly not needed).
Deep ISO/QMS background (not the focus of this role).
Seniority Level
Senior or Expert-level consultant, able to operate independently with minimal guidance.
Must be capable of representing Quality in high-level technical discussions and decision-making forums.