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Job Description:

We are searching for the best talent for a Senior Design Quality Engineer.

Purpose

We are looking for a Senior Design Quality Engineer to join our team.

In this role, we provide design quality and compliance expertise to support the development of new products and improvements to existing products. We work closely with cross‑functional teams to ensure customer needs are met while maintaining compliance with applicable regulations and company requirements.

This role plays a key part in design control, risk management, and quality system activities across the product lifecycle, including development, manufacturing, and post‑market support.

You will be responsible for

• Ensuring Design Control and Risk Management activities comply with applicable processes and regulatory requirements

• Acting as a Design Quality team member supporting new product development and lifecycle management activities

• Providing guidance on medical device regulations and design control requirements across global markets

• Supporting product development teams in the effective application of design controls and risk management principles

• Partnering with design teams to define design inputs and outputs, support verification and validation activities, and contribute to process validation, design transfer, and launch planning

• Ensuring critical‑to‑quality requirements are identified and translated into design and process specifications

• Supporting and developing risk management activities, including identification of risks and implementation of control measures

• Managing and delivering quality outputs for R&D projects

• Providing guidance and support to Design Quality Engineers and Quality Engineers

• Coordinating Design Quality resources to support business priorities, where needed

• Engaging with cross‑functional partners to resolve issues and drive alignment

• Applying structured problem‑solving approaches to identify, communicate, and resolve quality issues

• Supporting design reviews and maintaining accurate design control records

• Reviewing and approving R&D and production batch documentation, including sterilization records, to support timely project progression

• Supporting bench testing activities as required

• Monitoring Quality Management System data and identifying trends or issues

• Leading or supporting quality system improvement activities, including CAPA and nonconformance management

• Supporting internal and supplier audits and participating in inspections as needed

• Collaborating with Regulatory Affairs on submissions and deliverables

• Supporting complaint investigations, escalation activities, and post‑launch CAPA where required

• Delivering quality system training and promoting quality awareness across the organization

• Ensuring compliance with all applicable regulations, policies, and procedures

Qualifications / Requirements

• Degree in an engineering or technical discipline

• Minimum 5 years of experience in the medical device, IVD, or pharmaceutical industry

• Experience working with Quality Management Systems and design control processes

• Strong knowledge of design control, risk management, sterilization, and quality assurance processes

• Working knowledge of 21 CFR 820 and ISO 13485, with familiarity of global regulatory requirements

• Experience preparing for and participating in regulatory inspections (e.g., FDA, Notified Body)

• Ability to manage multiple projects and prioritize effectively in a dynamic environment

• Strong problem‑solving skills and ability to identify and address key quality risks

• Ability to work independently and collaboratively within cross‑functional and global teams

• Clear communication skills, with the ability to present complex information in a structured way

• Ability to build strong working relationships across functions such as Product Development, Regulatory Affairs, Manufacturing, and Marketing

• Demonstrates an understanding of AI concepts and frameworks, including awareness of responsible and ethical AI practices, and uses effective prompting techniques to support efficiency and productivity

What we offer

We offer a collaborative and inclusive environment where we work together to deliver high‑quality products and continuously improve our processes. This role provides opportunities to contribute to innovative product development, strengthen technical expertise, and grow within the organization.

Our commitment to inclusion

We are an equal opportunity employer and value diversity in our workforce. We welcome applications from people of all backgrounds, experiences, and perspectives.

If reasonable accommodation is needed during the recruitment process or while performing the role, support is available at every stage—please let us know how we can help.

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Required Skills:

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The anticipated base pay range for this position is:

Benefits:

In addition to base pay, we offer the following benefits*: an annual bonus with set target (% of pay) depending on pay grade / location, where the actual amount is based on the employees’ and companies’ performance of the previous calendar year, or sales commissions. Moreover, we offer vacation days, parental leave for a minimum of 12 weeks, bereavement leave, caregiver leave, volunteer leave, well-being reimbursement, programs for financial, physical and mental health. We also offer service anniversary and recognition awards, and subject to the terms of their respective plans, employees - and in some location’s eligible dependents - can participate in several insurance plans. For more information, visit Employee benefits | Supporting well-being & career growth | Johnson & Johnson Careers.

*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.