Lead Design Quality Engineer - Medical Devices

Lead Design Quality Engineer - Medical Devices

A global healthcare organisation developing complex, regulated medical devices is seeking a Lead Design Quality Engineer to play a key role in product development and lifecycle quality. Operating in a highly regulated, innovation-driven segment of the medical device market, the company brings clinically meaningful technologies to healthcare providers worldwide, where patient safety, compliance, and manufacturing excellence are essential.
This is a senior, hands-on quality leadership role with real influence across design, risk management, verification and validation, and supplier engagement.

The Role

The Lead Design Quality Engineer provides technical leadership and hands-on support across the full design and development lifecycle of medical devices. Acting as the Quality voice within cross-functional teams, this individual ensures products are designed, validated, and manufactured in compliance with global regulatory and quality standards, while also mentoring and guiding other engineers.
The role requires strong experience in medical device manufacturing, design controls, FMEAs, and applied quality engineering tools, combined with the ability to partner effectively with R&D, Operations, and external suppliers.

Key Responsibilities

Design Quality & Leadership

• Act as the Quality representative on product and process development teams.
• Lead and ensure effective execution of design control activities, including design reviews, verification, validation, specifications, and documentation.
• Provide guidance to engineering teams on quality engineering methodologies and best practices.
• Coach and review work of junior quality engineers and specialists.

Risk Management

• Lead risk management activities throughout product development using FMEAs and related tools.
• Partner with design and leadership teams to identify, assess, and mitigate product and process risks.

Verification & Validation

• Participate in the development and review of master test plans, traceability matrices, and validation strategies.
• Evaluate test protocols and reports to confirm regulatory compliance and technical adequacy.
• Support the creation, evaluation, and validation of product and process test methods.

Manufacturing & Supplier Quality

• Support design for manufacturability to ensure products can be consistently built and tested.
• Lead supplier quality activities, including new tooling qualification and PPAP.
• Participate in supplier selection and specification reviews.
• Define quality characteristics and inspection plans for components, subassemblies, and finished devices.

CAPA & Nonconformance

• Lead or support investigations into complex product issues and nonconformances.
• Drive root cause analysis and corrective actions aligned with quality system requirements.
• Evaluate and disposition nonconforming materials used in pilot and clinical builds.

Regulatory & Compliance

• Ensure compliance with FDA and international medical device regulations and standards.
• Maintain current knowledge of applicable regulatory requirements.
• Represent the organization during FDA, notified body, and internal audits as required.

Continuous Improvement

• Identify and lead opportunities for process and system improvements across functions.
• Promote continuous improvement in design control execution and use of quality tools.
• Apply statistical methods to analyze data and support decision-making.

What They're Looking For

• 7+ years of experience in Quality Engineering within the medical device industry.
• Strong understanding of medical device manufacturing, design control principles, and risk management (FMEAs).
• Proven experience leading cross-functional teams in a regulated product development environment.
• Solid working knowledge of FDA and international regulatory standards.
• Strong analytical, problem-solving, communication, and technical writing skills.
• Bachelor's degree or higher in Engineering, Science, or a related field.
• ASQ Certified Quality Engineer (or equivalent) strongly preferred.
• Experience in women's health or related therapeutic areas is a plus.

Compensation & Benefits

• Competitive base salary aligned with senior medical device quality leadership roles
• 10% annual bonus
• Exceptional benefits package typical of a global healthcare organisation, including comprehensive health coverage, retirement programs, and wellbeing support
• Opportunities for long-term career growth within a values-driven, quality-focused organization

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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