Phamaceutical Quality Engineer

This Jobot Job is hosted by: Amanda Preston
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Salary: $110,000 - $135,000 per year

A bit about us:

We are a global leader in scientific testing, inspection, and advisory services, supporting the world's most innovative pharmaceutical and biotechnology organizations. Our teams partner with clients across the product lifecycle, from early development through commercialization, delivering high-quality, data-driven solutions that support regulatory compliance and patient safety.

With a strong reputation for technical excellence and a collaborative, client-focused approach, we provide an environment where scientific expertise and innovation come together to solve complex challenges in regulated industries.

Why join us?

This is an opportunity to work at the intersection of pharmaceuticals and medical devices, supporting cutting-edge combination product programs that directly impact patient outcomes. You will collaborate with cross-functional teams and leading organizations in the industry while contributing to high-visibility, regulatory-critical initiatives.

We offer a dynamic environment where you can expand your technical expertise, take ownership of meaningful projects, and play a key role in shaping best practices across combination product development and quality systems.

Job Details

We are seeking a highly motivated engineer or scientist with experience in combination products and/or medical devices to support design control, risk management, and regulatory compliance activities. This individual will play a key role in ensuring that development programs meet global regulatory standards while advancing innovative drug-device products.

Key Responsibilities
Lead design control and risk management activities for combination product development programs, ensuring all deliverables are properly authored, reviewed, and maintained to support clinical and commercial milestones
Support and facilitate risk management activities with external design partners and manufacturing sites
Ensure all development activities align with applicable quality and regulatory standards, both internal and external
Provide input into design validation activities, including human factors and usability engineering assessments
Evaluate external design partners and suppliers to ensure quality systems, facilities, and processes meet development and production requirements
Support investigations related to device design and manufacturing for clinical and commercial products
Contribute to the development of regulatory submission content for device and combination product programs
Participate in internal and external audits of quality management systems
Identify opportunities for continuous improvement within combination product systems and processes
Collaborate across cross-functional teams to support broader organizational initiatives
Qualifications
Bachelor's, Master's, or PhD in a relevant scientific or engineering discipline (e.g., Chemistry, Biology, Biomedical Sciences, Mechanical Engineering, Materials Science, Chemical Engineering, or related field)
Experience within pharmaceutical combination products and/or medical device industries
Strong knowledge of applicable regulations and standards including ISO 13485, ISO 14971, ISO 9001, 21 CFR 820, 21 CFR Part 4, and EU MDR
Experience with design controls and device risk management processes
Familiarity with Human Factors Engineering and Usability Engineering principles
Working knowledge of standards such as EN 62366, EN 60601, and EN 62304
Understanding of device assembly and manufacturing processes
Experience performing complex data analysis to support engineering and quality decisions
Familiarity with Good Manufacturing Practices (GMP)
Skills and Competencies
Strong project management capabilities with the ability to provide technical leadership
High attention to detail with a focus on accuracy and quality
Ability to manage multiple priorities and work across concurrent projects
Capable of working independently with minimal supervision
Strong collaboration skills within cross-functional teams
Excellent communication skills, both written and verbal
Proficiency in standard business software (Word, Excel, PowerPoint)
Ability to quickly learn and apply established procedures in a consistent and reliable manner

Interested in hearing more? Easy Apply now by clicking the "Apply Now" button.

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