3186 IT & Software Developer jobs in the US
Pharmaceutical Quality Engineer
$110,000 - 135,000
Jobot
Lititz Pike 2701, Neffsville
$110,000 - 135,000
Requirements
Must:
- Bachelors, Masters, 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 in pharmaceutical combination products and/or medical device industries
- Strong understanding of applicable regulations and standards including ISO 13485, ISO 14971, ISO 9001, 21 CFR 820, 21 CFR Part 4, and EU MDR
- Proficiency in design controls and device risk management processes
- Familiarity with Human Factors Engineering and Usability Engineering principles
- Knowledge of standards such as EN 62366, EN 60601, and EN 62304
- Comprehension of device assembly and manufacturing processes
- Experience in complex data analysis for engineering and quality decisions
- Familiarity with Good Manufacturing Practices (GMP)
- Strong project management skills with the ability to lead technical efforts
- High attention to detail with a focus on accuracy and quality
- Capacity to manage multiple priorities and handle concurrent projects
- Skilled in working independently with minimal oversight
- Strong collaboration capabilities within cross-functional teams
- Excellent communication skills, both written and verbal
- Proficient in standard business software (Word, Excel, PowerPoint)
- Ability to quickly learn and uphold established procedures consistently and reliably
Responsibilities
- Lead design control and risk management efforts for combination product development initiatives, ensuring proper authorship, review, and maintenance of all deliverables to support clinical and commercial goals
- Facilitate risk management processes with external design partners and manufacturing sites
- Ensure all development activities adhere to applicable quality and regulatory standards, both internal and external
- Contribute to design validation efforts, including assessments of human factors and usability engineering
- Evaluate external design partners and suppliers to confirm compliance with development and production requirements
- Assist in investigations related to device design and manufacturing for clinical and commercial products
- Help develop regulatory submission materials for device and combination product initiatives
- Engage in internal and external audits of quality management systems
- Identify opportunities for ongoing improvement within combination product systems and processes
- Collaborate across cross-functional teams to support broader organizational goals
Description
We are a global leader in scientific testing, inspection, and advisory services, dedicated to supporting innovative pharmaceutical and biotechnology organizations. Our teams collaborate with clients throughout the product lifecycle, from early development through commercialization, delivering high-quality, data-driven solutions that ensure regulatory compliance and enhance patient safety. By fostering a culture of technical excellence and a client-centric approach, we create an environment where scientific expertise and innovation unite to tackle complex challenges in regulated industries. This position offers an exciting opportunity to work at the intersection of pharmaceuticals and medical devices, making a direct impact on patient outcomes while expanding your technical expertise in a dynamic setting.
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The company with most openings is Lockheed Martin Corporation as they are hiring for 274 different Machine Learning Engineer jobs in the United States. They are probably quite committed to find good Machine Learning Engineers.
The company with most openings is Lockheed Martin Corporation as they are hiring for 274 different Machine Learning Engineer jobs in the United States. They are probably quite committed to find good Machine Learning Engineers.