Phamaceutical Quality Engineer

Jobot; Broderick (CA); On-site; USD 110,000 - 135,000; Full time

Job summary

A leading scientific testing firm in California is seeking a highly motivated engineer or scientist experienced in combination products and medical devices. You will lead design control, risk management, and ensure compliance with global regulatory standards. The ideal candidate has a strong scientific background and collaboration skills. This role offers an innovative environment where you can contribute to high-impact projects and be part of a dynamic team. Salary is competitive at $110,000 - $135,000 per year.

Qualifications

• Bachelor’s, Master’s, or PhD in Chemistry, Biology, Biomedical Sciences, Mechanical Engineering, Materials Science, or Chemical Engineering.
• Experience in pharmaceutical combination products and/or medical device industries.
• Strong knowledge of ISO regulations and standards.

Responsibilities

• Lead design control and risk management activities for combination product programs.
• Support risk management activities with external partners.
• Ensure development activities align with quality and regulatory standards.

Skills

Project management

Attention to detail

Collaboration

Communication skills

Data analysis

Education

Bachelor’s, Master’s, or PhD in a relevant scientific or engineering discipline

Tools

Word

Excel

PowerPoint

Job description

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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

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