Senior Medical Device Quality Engineer

GSK•Upper Providence, PA

2d•Hybrid

About The Position

This position ensures products meet safety, regulatory, and quality standards from design and development to first product launch for medical devices within combination products. Responsibilities include quality oversight of device design control activities, risk management, root cause analyses, and Design and Development File (DDF). You will lead quality engineering activities for medical device products in the United States. You will work across design, manufacturing, and regulatory teams to ensure product safety, reliability, and compliance. We value clear communicators who solve problems with data and practical judgment. You will grow your career by influencing product quality and patient outcomes while working with talented, multidisciplinary teams aligned to our mission of uniting science, technology and talent to get ahead of disease together.

Requirements

Bachelor’s degree in biomedical, mechanical, electrical engineering, quality engineering, or equivalent level of knowledge.
Minimum 5 years’ experience in pharmaceutical and/or biopharmaceutical or related industries, with experience in manufacturing and quality oversight of medical devices or combination products, with preferred experience in management of pre-filled syringe and autoinjector assembly.
Experience conducting investigations, root cause analysis, CAPA management for quality and manufacturing issues, change controls, process validation.
Experience participating in risk management discussions, particularly as it relates to cascading identified product issues/hazards into potential user harms is an asset.
Experience with design controls, risk management, and Design and Development Files (DDF)/ Design History File (DHF) requirements.
Knowledge of global regulations and guidance, global regulatory expectations, inspection intelligence, new technologies, industry standards and registered risks pertaining to medical devices.
Working knowledge of quality systems and standards relevant to medical devices, such as ISO 13485 and FDA 21 CFR part 820.
Hands-on experience with root cause analysis and CAPA (corrective and preventive action) execution.
Ability to read and review technical drawings, specifications, and test data.

Nice To Haves

Advanced degree in engineering or quality-related discipline.
Experience with risk management standards such as ISO 14971.
Familiarity with supplier quality management and supplier audits.
Proficiency with statistical tools, design of experiments (DOE), and process capability analysis.
Experience supporting regulatory submissions or inspections.
Experience with medical device software or combination product quality.

Responsibilities

Provide quality oversight of device design control activities for new combination products from clinical design planning through first commercial product launch.
Ensure compliance with relevant FDA, ISO, EU MDR, global, and GSK requirements for medical devices within combination products.
Provide quality oversight of risk management files (ISO 14971) and Design and Development Files (ISO 13485).
Review/Approve technical documentation, quality plans, and support new product development and introduction.
Support and contribute to device development process and QMS improvements.
Lead investigations for device nonconformances, deviations, and complaints.
Ensure customer feedback is considered as part of the development of new combination products and consistency across products using the same device platform ensuring patient safety and quality.
Lead R&D inspection readiness for device related areas and act as the Subject Matter Expert (SME) for regulatory inspections and audits.
Partner with suppliers and internal teams to resolve component quality issues and support supplier quality management.