Senior Medical Device Quality Engineer

WIB-Pittsburgh

Collegeville (PA)

On-site

USD 120,000 - 150,000

Full time

6 hours ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Job summary

GSK in Collegeville, Pennsylvania, is seeking a Senior Medical Device Quality Engineer to oversee design controls, risk management, and DDF/DHF activities for combination products. You will ensure FDA/ISO compliance and lead investigations, CAPA, and regulatory readiness across cross-functional teams.

The role emphasizes data-driven problem solving, collaboration with manufacturing and regulatory colleagues, and advancing patient safety through robust quality systems.

Qualifications

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 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.

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.
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.

Skills

Design controls

Risk management

CAPA

Root cause analysis

DHF/DDF knowledge

FDA/ISO knowledge

Technical drawings

Education

Bachelor's degree in biomedical/ mechanical/ electrical engineering or quality engineering

Advanced engineering degree (preferred)

Job description

Career Center Home
Search Jobs
Senior Medical Device Quality Engineer

5 mi/8 km 10 mi/15 km 25 mi/40 km 50 mi/80 km 100 mi/160 km 200 mi/320 km

Results

Job Details

Explore Location

Senior Medical Device Quality Engineer

Share Print

GSK

Collegeville, Pennsylvania, United States

(on-site)

Posted 5 hours ago

Senior Medical Device Quality Engineer

Share Print

GSK

Collegeville, Pennsylvania, United States

(on-site)

Job Function

Other

Senior Medical Device Quality Engineer

The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.

Senior Medical Device Quality Engineer

The insights provided are generated by AI and may contain inaccuracies. Please independently verify any critical information before relying on it.

Description

Business Introduction:

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients' needs and drive our performance. Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it's vital to bring our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply. We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

Position Summary

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.

Key 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.

Qualifications

Basic Qualifications:

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.

Preferred Qualifications

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.

Work Arrangement

This role is hybrid, with regular onsite collaboration in the United States and some remote flexibility. Travel may be required for supplier visits, audits, or cross-site collaboration.

What We Offer You

You will join a team focused on meaningful, measurable impact for people who need better health outcomes. You will receive opportunities to develop technical skills, lead important projects, and grow your career. We support an inclusive environment where everyone can contribute and learn.

Skills

Data Integrity, Digital Fluency, GxP Regulations, Influencing Without Authority, Lean Management, Pharmaceutical Regulatory Compliance, Problem Solving, Project Management, Quality Assurance (QA), Quality Management Systems (QMS), Risk Awareness, Technical Writing

Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.

Why GSK

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.

If you require an accommodation or other assistance to apply for a job at GSK, please contact the appropriate Recruitment Staff by emailing us at - usrecruitment.adjustments@gsk.com

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/

Job ID: 86106391

GSK

Websitewww.gsk.com US Headquarters: Philadelphia, PA Size:10000+ employees Founded: 1830 Type: Company - Public (GSK) Industry: Biotech & Pharmaceuticals Revenue: $10+ billion (USD) per year Video: https://youtu.be/RBdgq5VTQmM We are a science-led global healthcare company. We research and develop a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We also have a significant global presence with commercial operations in more than 150 countries, a netwo...

View Full Profile

More Jobs from GSK