Senior Quality Engineer

Aurora Lifesciences; Yorkshire (VA); Hybrid; USD 90,000 - 120,000; Full time

Job summary

Aurora Lifesciences is seeking a Senior Quality Engineer to join its growing medical device operations in the Virginia area. You will work closely with Quality, Manufacturing, Engineering and Operations, providing hands-on QA support across product life cycles and quality systems.

The role focuses on developing and qualifying manufacturing processes, leading quality investigations, and driving CAPAs and continuous improvement initiatives in a fast-paced environment.

Qualifications

• Engineering or science degree in a relevant technical field.
• Approximately 4+ years of quality engineering experience in medical devices.
• Knowledge of 21 CFR Part 820 / FDA QSR.
• Understanding ISO 14971 and medical device risk management.

Responsibilities

• Provide hands-on Quality Engineering support across manufacturing, validation, design changes, continuous improvement and Quality Systems.
• Develop, optimise and qualify manufacturing processes in collaboration with Manufacturing Engineering.
• Support and approve engineering and design changes.
• Create, review and approve IQ/OQ/PQ validation protocols and reports.
• Support the Validation Master Plan and site QA activities.
• Lead risk management activities including Process FMEA.
• Drive root cause analysis and implement corrective/preventive actions.

Skills

Quality engineering

Manufacturing

Risk management

Root cause analysis

CAPA

Auditing

Mentoring

Project ownership

Education

Engineering degree

Science degree

Tools

IQ/OQ/PQ

Gage R&R

CAPA system

Job description

An exciting opportunity has arisen for an experienced Senior Quality Engineer to join a growing medical device organisation at a key stage of its development.

The business is investing in its manufacturing capability, strengthening its Quality function and preparing for continued growth. This role will sit at the centre of that journey, providing hands-on Quality Engineering support across manufacturing, validation, design changes, continuous improvement and Quality Systems.

This is an opportunity to do more than maintain an established system. You will have the chance to influence how Quality Engineering operates as the business scales, lead improvement projects, work closely with senior stakeholders and become a key technical point of contact within the Quality team.

For someone looking for increased responsibility and visibility, there is significant scope to develop alongside the organisation as the Quality function continues to grow.

The Role

You will work closely with Quality, Manufacturing, Engineering and Operations, providing technical Quality Engineering support across the product and manufacturing lifecycle.

Key responsibilities will include:

• Partnering with Manufacturing Engineering to develop, optimise and qualify manufacturing processes.
• Supporting and approving engineering and design changes.
• Providing Quality Engineering input into new manufacturing processes, procedures and equipment.
• Creating, reviewing and approving IQ/OQ/PQ validation protocols and reports.
• Supporting the development and execution of the site's Validation Master Plan.
• Supporting design verification and validation activities.
• Leading and supporting process validation, equipment qualification and Gage R&R studies.
• Reviewing manufacturing documentation and production records to ensure products are manufactured in accordance with regulatory and Quality System requirements.
• Leading cross-functional risk management activities, including Process FMEA and supporting risk documentation.
• Identifying and leading continuous improvement and process optimisation initiatives.
• Conducting manufacturing floor audits and ensuring processes remain compliant with approved procedures.
• Planning and performing internal and supplier audits.
• Supporting equipment maintenance, calibration and preventative maintenance requirements where applicable.
• Leading or supporting investigations into manufacturing and Quality non-conformances.
• Driving structured root cause analysis and supporting the implementation of effective corrective and preventive actions.
• Supporting Quality System activities including NCRs, CAPAs, complaints and post-market Quality activities.
• Acting as a senior technical resource within the Quality team and mentoring less experienced Quality Engineers.
• Taking ownership of Quality Engineering projects that support the continued growth and development of the manufacturing operation.

What We're Looking For

We are looking for someone who combines strong medical device Quality Engineering knowledge with a practical, hands-on approach.

You will ideally have:

• A degree in Engineering, Science or another relevant technical discipline.
• Approximately 4+ years' Quality Engineering experience within medical devices
• Familiarity with 21 CFR Part 820 / FDA Quality System requirements.
• Good understanding of ISO 14971 and medical device risk management.
• Experience investigating non-conformances and completing structured root cause investigations.
• Experience with CAPA and corrective/preventive action implementation.
• Practical experience of IQ/OQ/PQ and process validation.
• Experience producing and reviewing validation protocols, technical reports and Quality documentation.
• Exposure to manufacturing Quality and working directly with production and engineering teams.
• Experience of internal and/or supplier auditing

What Will Make You Successful

This role will suit someone who enjoys being close to the manufacturing operation rather than working purely behind a desk.

You should be comfortable:

• Taking ownership of projects and seeing them through from investigation to implementation.
• Working across Quality, Engineering, Manufacturing and Operations.
• Challenging existing processes and identifying better ways of working.
• Prioritising multiple projects within a growing environment.
• Communicating technical Quality issues clearly to both technical and non-technical stakeholders.
• Producing high-quality technical documentation.
• Using data and structured problem-solving techniques to make informed decisions.