Careers
Our team is growing! Learn more about our current opportunities below.
FDA 510(k) Submissions: Lead and assist clients in preparing, reviewing, and submitting FDA 510(k) pre-market notifications for medical devices. Ensure compliance with relevant regulations and guidelines.
Design History File (DHF) Generation and Maintenance: Oversee and support the creation, review, and maintenance of DHFs for medical devices, documenting the product development process and ensuring alignment with applicable standards and requirements.
ISO 14971 Risk Analysis: Conduct comprehensive risk assessments for medical devices according to ISO 14971 standards. Work with clients to identify and mitigate potential risks associated with the design, manufacture, and use of their products.
IEC 62304 Requirements: Provide guidance and expertise on compliance with the IEC 62304 standard, ensuring clients’ software life cycle processes meet the necessary regulatory requirements.
Quality Management Systems (QMS): Assist clients in implementing and improving their QMS to comply with relevant quality standards, regulations, and industry best practices.
Audits and Inspections: Participate in audits and regulatory inspections, both internally and on behalf of clients. Hold ISO 13485 auditor and EU MDR certifications to support the resolution of any identified non-conformances and collaborate on corrective and preventive actions.
Training and Knowledge Sharing: Conduct training sessions and workshops for clients’ teams, imparting your expertise on quality assurance, regulatory compliance, and best practices in the medical device industry.
Continuous Improvement: Continuously evaluate and enhance internal processes and methodologies to ensure the delivery of high-quality consulting services to clients.
Industry Updates: Stay abreast of changing regulatory requirements, industry trends, and advancements in quality management practices, and apply this knowledge to support clients effectively.
Qualifications:
- Bachelor’s degree in Engineering, Life Sciences, or a related field. ISO 13485:2016, EU MDR, and/or MDSAP training certifications are also preferred. Advanced degrees are advantageous.
- Proven experience (3-6 years) in quality engineering or related roles within the medical device industry including demonstrable evidence of:
Design History File (DHF) generation and/or remediation
Design Validation planning
Project Leadership
- Expertise in FDA 510(k) submissions, DHF generation and maintenance, ISO 14971 risk analysis, and familiarity with IEC 62304 requirements.
- Strong knowledge of quality management systems (e.g., ISO 13485) and regulatory frameworks (FDA, EU MDR, etc.).
- Experience in conducting audits, inspections, and interacting with regulatory agencies is a plus.
- Excellent problem-solving, analytical, and communication skills to effectively collaborate with clients and internal teams.
- Ability to work independently, manage multiple projects simultaneously, and meet tight deadlines.
- Strong attention to detail, and a passion for maintaining the highest quality standards.
Benefits:
- Collaborative team dedicated to working to support medical device innovation and compliance
- Remote working and flexible hours
- PTO
- Health and Dental Insurance
- 401k
- Employee training and certifications provided
CASE STUDY
Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD.
Provide Quality Engineering support for the design, risk analysis, and verification/validation of new medical device products.
Work closely with startup medical device companies and products to ensure all aspects of the design history file, technical file, and risk management file are completed during the development process.
Assist product development teams during development of new devices and software. Responsible for implementation of product quality plans, verification/validation protocols and reports.
Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements. Keep current on all applicable best practices and statutory regulations governing the design, procurement, manufacture, marketing, and distribution of medical devices.
Conduct and support internal and external audits for clients to maintain compliance with the FDA, ISO 13485, CE Mark (MDR), MDSAP.
Support post-market activities including CAPA, non-conformances, complaint handling and investigation, supplier assessment, adverse event reporting, and other activities.
Candidates are able to work remotely from home with optional travel as needed.
Qualifications:
- Bachelor’s degree or equivalent in Engineering or related field
- 1-5+ years’ of industry experience
- Strong knowledge of quality tools used in the industry
- Analytical and quantitative approach to problem solving
- Strong communications skills
Benefits:
- Collaborative team dedicated to working to support medical device innovation and compliance.
- Remote working and flexible hours
- PTO
- Health and Dental Insurance
- 401k
- Employee training and certifications provided
Work as a quality consultant for medical device companies and various types of devices, diagnostics, and SaMD.
Provide Software Quality Engineering support for the design, risk analysis, and verification/validation of new medical device software products.
Strong working knowledge of IEC 62304, AAMI TIR45, Agile methodology, software design and testing.
Work closely with startup medical device companies and products to ensure all aspects of the software design file and risk management file are completed during the development process.
Assist product development teams during development of new devices and software to ensure proper documentation and records are created.
Responsible for implementation of product quality plans, verification/validation protocols and reports.
Maintain quality system processes and procedures to ensure compliance to all domestic and international standards or requirements.
Qualifications:
- Bachelor’s degree or equivalent in Engineering or related field
- 1-3+ years’ of industry experience
- Strong knowledge of software development and tools used in the industry
- Analytical and quantitative approach to problem solving
- Strong communications skills
Benefits:
- Collaborative team dedicated to working to support medical device innovation and compliance
- Remote working and flexible hours
- PTO
- Health and Dental Insurance
- 401k
- Employee training and certifications provided
Location: Atlanta or Remote
Job Type: Internship (Part-Time or Full-Time)
Duration: 6-12 months
Compensation: 20 p/h
Rook Quality Systems is a consulting firm that provides expert regulatory and quality system support to medical device companies of all sizes, ensuring compliance with FDA regulations, ISO certifications, and global market requirements. We are seeking a Marketing & Graphic Design Intern who is passionate about content creation, video editing, and leveraging AI tools to enhance marketing efforts. This is an exciting opportunity to gain hands-on experience in the medical device industry, work with cutting-edge AI technologies, and develop impactful marketing materials.
- Assist in creating engaging marketing content, including graphics, videos, presentations, and promotional materials.
- Edit and produce video content for social media, website, and internal communications.
- Design compelling presentations and visual assets for sales and marketing teams.
- Leverage AI tools to enhance content creation and marketing automation.
- Support social media campaigns, including content scheduling and engagement tracking.
- Collaborate with the marketing team to develop creative strategies for branding and outreach.
- Assist in website updates, blog content, and email marketing initiatives.
- Conduct industry research and analyze trends to inform marketing efforts.
- Currently pursuing or recently completed a degree in Marketing, Graphic Design, Communications, Digital Media, or a related field.
- Experience with AI-powered design and content tools (e.g., Canva AI, ChatGPT, DALL·E, Descript, Runway).
- Ability to create visually appealing content with a keen eye for detail and aesthetics.
- Basic video editing skills and a passion for multimedia content creation.
- Strong communication and organizational skills with a proactive and eager-to-learn attitude.
- Interest in the medical device or healthcare industry is a plus, but not required
- Hands-on experience in the medical device industry with real-world marketing challenges.
- Exposure to AI-powered marketing tools and cutting-edge design technologies.
- Mentorship from industry professionals and opportunities for skill development.
- A dynamic and collaborative work environment.
- Potential for future employment opportunities based on performance.
Interested candidates should submit their resume, portfolio (if available), and a brief cover letter explaining why they are a great fit for this role using the Apply form by clicking the “APPLY” button below or emailing info@rookqs.com.
We look forward to seeing your creativity in action!