Director, Global Device Quality, global level Medical Device industry experience required

A New Beginning-Genesis 2; United States; On-site; USD 130,000 - 170,000; Full time

Benefits offered by this job

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid maternity leave

Tuition assistance

Job summary

A leading global medical device company is seeking a Director of Global Device Quality. This role requires extensive experience in device and combination product quality oversight and regulatory compliance. The ideal candidate has at least 10 years in medical device quality or design assurance and robust skills in risk management and design controls. The position includes leadership responsibilities across device development activities and requires effective collaboration with cross-functional teams to ensure high-quality standards and regulatory adherence.

Qualifications

• Minimum 10 years in medical device quality or design assurance.
• 7+ years focused on new product development for combination products.
• Strong facilitation and negotiation skills.

Responsibilities

• Lead device quality oversight across product portfolio.
• Ensure compliance with global regulatory expectations.
• Provide input to regulatory submissions.

Skills

Leadership in device quality oversight

Risk management

Regulatory compliance

Design control

Technical writing

Education

BA/BS in Mechanical Engineering

Advanced degree desirable

Job description

Director, Global Device Quality, global level Medical Device industry experience required

North American residents only

Those people willing to work in, reside in California may be considered 1st

If you are fully qualified "PLEASE" feel free to call 860 889 4141 until 8 PM EST 7 days a week as you can take notes & "after" you email a resume to me

[e-mail]

GRAZIE

Joe

Role Overview

The Director, Global Device Quality serves as the strategic and operational leader responsible for device and combination product quality oversight across our drug–device combination product portfolio throughout the product lifecycle—from early clinical development through commercialization and lifecycle management.

This role defines and executes the global device quality strategy, ensuring compliance with applicable regulatory requirements (e.g., 21 CFR Part 4, ISO 13485, ISO 14971, IEC 62366) while enabling robust design control, risk management, and verification/validation frameworks for device constituents and the combination product.

This leader will provide hands on engagement on design controls, risk management, verification and validation, usability engineering, and design transfer readiness. The Director role will serve as a member of cross functional teams to embed quality by design, influence product strategy, and ensure that combination products meet internal QMS requirements, international regulatory expectations and delivers high performing device solutions that support patient needs.

Key Responsibilities

• Serve as the Device Quality representative within the Global Quality organization, ensuring alignment on combination product quality strategy, risk posture, and key program deliverables.
• Provide quality leadership across device development activities, including design control, verification and validation, risk management, and regulatory compliance.
• Provide quality oversight of design control activities, including design inputs, design outputs, verification, validation, and design transfer to ensure compliance with global regulatory expectations.
• Ensure effective development and maintenance of Design History Files (DHF) in accordance with FDA and global regulatory requirements.
• Review and approve device verification and validation protocols and reports to ensure robust device performance and regulatory compliance.
• Provide input to the risk management framework for combination products in alignment with ISO 14971, ensuring proactive identification, mitigation, and monitoring of patient safety risks associated with device components.
• Provide quality oversight of human factors and usability engineering strategies to ensure alignment with regulatory expectations and user needs.
• Provide quality oversight for device testing strategies including mechanical performance, biocompatibility, extractables and leachables, container closure integrity, and device-related stability considerations.
• Partner with Device Engineering, Regulatory Affairs, Drug Product Development, and Supply Chain teams to ensure alignment on device specifications, control strategies, and overall product quality requirements.
• Provide quality input to regulatory submissions and health authority interactions related to device constituents of combination products.
• Prepare for and support internal design audits and external regulatory inspections focused on design controls and risk management.
• Interface with device suppliers and external partners to influence quality practices, ensuring alignment with applicable regulations.
• Maintain oversight of device-related product quality risks and ensure timely identification, mitigation, and escalation of issues to program teams and senior management as appropriate.
• Lead cross-portfolio initiatives to improve device quality systems, processes, and operational effectiveness.
• Be the voice of device quality in the broader company ecosystem.
• Other duties as assigned.

Periodic travel is required.

Experience/Education

• BA/BS in Mechanical Engineering, Biomedical Engineering, Quality Engineering, or related field or related field; advanced degree strongly desirable
• Minimum 10 years in medical device quality or design assurance with 7+ years focused on new product development for combination products Deep working knowledge of 21 CFR Part 4, 21 CFR 820, ISO 13485, ISO 14971, and applicable global regulatory expectations
• Proven experience authoring DHF content, leading V&V and test method validation, and executing complex risk management activities
• Strong facilitation, negotiation, and stakeholder management skills with a history of driving decisions in matrixed teams without direct reports
• Excellent technical writing and presentation skills for regulatory submissions, design reviews, and executive briefings
• Proven ability to influence strategic decisions and drive accountability across organizations

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Featured benefits Medical insurance, Vision insurance, Dental insurance, 401(k), Paid paternity leave, Paid maternity leave, Child care support, Commuter benefits, Tuition assistance, Disability insurance