Senior Device Quality Engineer

GSK•Zebulon, NC

1d•Onsite

About The Position

The Senior Device Quality Engineer provides quality and compliance leadership for manufacturing and packaging equipment at the Zebulon, NC site, ensuring systems and processes used to produce respiratory and solid dose medicines operate in full compliance with FDA, ISO 13485, GxP and GSK Quality Management System (QMS) requirements. This role supports new product introductions and site expansion, owns key elements of the device/equipment quality lifecycle (qualification, validation, change control, deviations, CAPA), and acts as a primary quality interface with Engineering, Production and Technical teams to maintain a strong safety and quality culture and inspection readiness. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Provide quality oversight of manufacturing and packaging equipment and associated processes, ensuring compliance with applicable FDA, ISO 13485, ISO 9001, GxP and GSK QMS standards throughout the equipment lifecycle (design, installation, qualification, operation and maintenance). Lead or provide quality approval for equipment validation and qualification (IQ/OQ/PQ), periodic reviews, and requalification activities; ensure validation documentation meets regulatory and internal requirements and is inspection ready. Serve as quality owner/approver for device- and equipment-related change controls, ensuring appropriate risk assessment, validation impact evaluation, and effective implementation in collaboration with Engineering, Production and Technical teams. Lead or provide significant quality input into deviations, non-conformances, root cause investigations and CAPA related to equipment, packaging devices and associated processes, using robust problem-solving tools and data to prevent recurrence. Support new product introductions (NPI) and site expansion projects by defining quality requirements for equipment and packaging devices, reviewing and approving technical documentation, and ensuring smooth transfer to commercial operations. Partner with Engineering and Operations to define and monitor quality performance metrics (e.g. rejects, deviations, equipment-related complaints), identify trends, and drive continuous improvement projects that strengthen compliance and product robustness. Act as a subject matter expert (SME) during internal and external inspections (e.g. FDA, other health authorities, Notified Bodies, internal audits) for equipment and device-related topics, ensuring sustained inspection readiness. Contribute to the maintenance and improvement of site Quality Management System procedures relevant to equipment, validation, change control, and deviation/CAPA management; provide training and coaching to cross-functional partners on these requirements. Collaborate with supplier quality and engineering teams on qualification, assessment and ongoing oversight of key external partners involved in equipment design, manufacture, installation and service, ensuring adherence to GSK quality expectations. Promote and model GSK’s Safety and Quality-first culture, actively participating in safety programs, risk assessments and quality improvement initiatives in the operational area.

Requirements

Bachelor’s degree in engineering (Mechanical, Electrical, Industrial, Chemical), Quality Engineering, or related technical discipline.
5+ years of experience in pharmaceutical, biotech or medical device manufacturing in a Quality, Validation or Engineering role with significant exposure to manufacturing/packaging equipment and devices.
Experience supporting or directly participating in regulatory inspections and internal audits, preferably in a senior or SME capacity.

Nice To Haves

Advanced degree (e.g. MS) in Engineering, Quality or related scientific discipline and/or professional quality certification (e.g. CQE, CQA, Six Sigma) is desirable.
Ability to work independently and prioritize workload.
Strong knowledge of FDA regulations, ISO 13485 and related device/equipment quality and validation expectations; familiarity with GxP, QMS and data integrity principles.
Demonstrated analytical and problem-solving skills, including use of tools such as 5-Whys, Fishbone/Ishikawa, FMEA, DMAIC and statistical analysis where appropriate.
Ability to interpret engineering drawings, equipment specifications, automation/controls requirements and technical reports, and translate them into clear quality requirements.
Excellent communication and influencing skills, with the ability to explain complex quality/technical topics to both technical and non-technical stakeholders and to challenge constructively when needed.
Strong planning and organizational skills with the ability to manage multiple priorities in a fast-paced, highly regulated environment.
Demonstrated commitment to safety, quality and continuous improvement, aligned with GSK’s values and expectations.

Responsibilities

Provide quality oversight of manufacturing and packaging equipment and associated processes, ensuring compliance with applicable FDA, ISO 13485, ISO 9001, GxP and GSK QMS standards throughout the equipment lifecycle (design, installation, qualification, operation and maintenance).
Lead or provide quality approval for equipment validation and qualification (IQ/OQ/PQ), periodic reviews, and requalification activities; ensure validation documentation meets regulatory and internal requirements and is inspection ready.
Serve as quality owner/approver for device- and equipment-related change controls, ensuring appropriate risk assessment, validation impact evaluation, and effective implementation in collaboration with Engineering, Production and Technical teams.
Lead or provide significant quality input into deviations, non-conformances, root cause investigations and CAPA related to equipment, packaging devices and associated processes, using robust problem-solving tools and data to prevent recurrence.
Support new product introductions (NPI) and site expansion projects by defining quality requirements for equipment and packaging devices, reviewing and approving technical documentation, and ensuring smooth transfer to commercial operations.
Partner with Engineering and Operations to define and monitor quality performance metrics (e.g. rejects, deviations, equipment-related complaints), identify trends, and drive continuous improvement projects that strengthen compliance and product robustness.
Act as a subject matter expert (SME) during internal and external inspections (e.g. FDA, other health authorities, Notified Bodies, internal audits) for equipment and device-related topics, ensuring sustained inspection readiness.
Contribute to the maintenance and improvement of site Quality Management System procedures relevant to equipment, validation, change control, and deviation/CAPA management; provide training and coaching to cross-functional partners on these requirements.
Collaborate with supplier quality and engineering teams on qualification, assessment and ongoing oversight of key external partners involved in equipment design, manufacture, installation and service, ensuring adherence to GSK quality expectations.
Promote and model GSK’s Safety and Quality-first culture, actively participating in safety programs, risk assessments and quality improvement initiatives in the operational area.