Lead Design Quality Engineer – Medical Devices
Hybrid Role | 2 Weeks On-Site in Falmouth, Cornwall / 2 Weeks Remote
A rare opportunity has opened for an experienced Lead Design Quality Engineer to join a global healthcare organisation developing complex, highly regulated medical devices that directly impact patient outcomes worldwide.
This role offers a highly attractive hybrid working model, two weeks working on-site in beautiful Falmouth, Cornwall followed by two weeks working remotely from home, providing the chance to collaborate closely with engineering teams while maintaining exceptional work‑life balance.
If you are a senior quality engineering professional who thrives in product development environments and wants real influence across design, risk, and manufacturing quality, this position offers the scope, visibility, and technical challenge to make a significant impact.
The Opportunity
As Lead Design Quality Engineer, you will play a key technical leadership role across the full product development lifecycle, acting as the Quality voice within cross‑functional teams and ensuring products are designed, validated, and manufactured in line with global regulatory standards and best‑in‑class quality systems.
You will work closely with R&D, manufacturing, and supplier partners, shaping quality strategy across design controls, risk management, verification & validation, and supplier quality.
This is a hands‑on leadership role where your expertise will influence both new product development and continuous improvement across the organisation.
Key Responsibilities
Design Quality Leadership
* Act as the Quality representative within product and process development teams
* Lead design control activities including design reviews, verification, validation, specifications, and documentation
* Provide technical guidance on quality engineering methodologies
* Mentor and review work of junior quality engineers and specialists
* Drive FMEA execution and risk mitigation strategies
* Partner with design teams to proactively manage product and process risks
Verification & Validation
* Support development of master test plans, traceability matrices, and validation strategies
* Review test protocols and reports for regulatory and technical compliance
* Support development and validation of product and process test methods
* Support Design for Manufacturability initiatives
* Lead supplier quality activities including PPAP and tooling qualification
* Participate in supplier selection and specification reviews
* Define quality characteristics and inspection strategies
CAPA & Non‑Conformance
* Lead investigations into complex product issues and nonconformances
* Drive root cause analysis and corrective actions
* Review and disposition nonconforming materials in pilot and clinical builds
Regulatory & Compliance
* Ensure compliance with FDA and international medical device regulations
* Represent Quality during FDA, notified body, and internal audits
* Identify opportunities to strengthen design control processes
* Apply statistical analysis and quality tools to support data‑driven decisions
* Drive continuous improvement initiatives across engineering and quality systems
What We’re Looking For
* 7+ years’ experience in Quality Engineering within the medical device industry
* Strong knowledge of design controls, risk management, and medical device manufacturing
* Proven ability to lead cross‑functional product development teams
* Solid understanding of FDA and international regulatory frameworks
* Excellent analytical, problem‑solving, and technical communication skills
* Bachelor’s degree or higher in Engineering, Science, or a related field
* ASQ Certified Quality Engineer (CQE) or equivalent preferred
* Experience in women’s health or related therapeutic areas is advantageous
* Competitive base salary aligned with senior medical device quality leadership roles
* 10% annual performance bonus
* Excellent global benefits package including comprehensive healthcare, retirement plans, and wellbeing support
* Strong long‑term career development opportunities within a global healthcare organisation
* 2 weeks on‑site in Falmouth, Cornwall followed by 2 weeks working from home
Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.
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