Quality Engineer (Pharmaceutical)

This Jobot Job is hosted by: Amanda Preston
Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.
Salary: $105,000 - $130,000 per year

A bit about us:

We are a global pharmaceutical organization dedicated to developing and delivering innovative therapies that improve patient outcomes worldwide. With a strong presence across both drug and device development, we operate at the forefront of combination products, integrating science, technology, and patient-centric design.

Our teams are committed to advancing quality, compliance, and innovation across the product lifecycle, ensuring that every product meets the highest standards of safety, efficacy, and regulatory excellence.

Why join us?

This is a unique opportunity to work within a highly regulated and innovation-driven environment at the intersection of pharmaceuticals and medical devices. You will play a critical role in supporting combination product development and commercial programs that directly impact patients' lives.

You will be part of a collaborative, cross-functional team where your expertise in quality and compliance will help shape product development, influence regulatory strategy, and drive continuous improvement across complex systems.

Job Details

Position Overview

We are seeking a Quality Engineer with experience in pharmaceutical, medical device, or combination product environments to support quality systems, design controls, and risk management activities. This role will partner closely with R&D, manufacturing, regulatory, and external partners to ensure compliance and quality throughout the product lifecycle.

Key Responsibilities
Support design control and risk management activities for combination product development programs
Ensure compliance with applicable quality and regulatory standards, including FDA and global requirements
Partner with cross-functional teams to support product development, validation, and commercialization efforts
Participate in risk assessments, including FMEA and hazard analyses, and support mitigation strategies
Support design verification and validation activities, including human factors and usability considerations
Contribute to regulatory submissions by supporting quality-related documentation and data
Investigate quality issues and support root cause analysis and CAPA implementation
Collaborate with external partners, including design firms and manufacturers, to ensure quality system alignment
Support internal and external audits and inspections
Identify and drive continuous improvement initiatives across quality systems and processes
Qualifications
Bachelor's, Master's, or PhD in Engineering or a related scientific discipline (e.g., Biomedical, Mechanical, Chemical, Materials, or Life Sciences)
3+ years of experience in pharmaceutical, medical device, or combination product environments
Strong understanding of design controls and risk management principles
Working knowledge of applicable standards and regulations, including ISO 13485, ISO 14971, 21 CFR 820, 21 CFR Part 4, and EU MDR
Familiarity with Human Factors / Usability Engineering is preferred
Understanding of Good Manufacturing Practices (GMP)
Experience with validation, verification, and quality system processes
Skills and Competencies
Strong analytical and problem-solving skills with attention to detail
Ability to manage multiple priorities in a fast-paced, regulated environment
Effective collaboration across cross-functional and global teams
Strong communication skills, both written and verbal
Ability to work independently while maintaining alignment with broader project goals
Proficiency in standard business tools and data analysis

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

Jobot is an Equal Opportunity Employer. We provide an inclusive work environment that celebrates diversity and all qualified candidates receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, age (40 and over), disability, military status, genetic information or any other basis protected by applicable federal, state, or local laws. Jobot also prohibits harassment of applicants or employees based on any of these protected categories. It is Jobot's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions.

Sometimes Jobot is required to perform background checks with your authorization. Jobot will consider qualified candidates with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.

By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: jobot.com/privacy-policy