Predicine is a molecular insight company developing genomic profiling tests and robust algorithms for cancer diagnostics and monitoring. Our biology-oriented approach to analyzing genomics is advancing the understanding of tumor mutational landscape. We are applying our expertise in genomic profiling to identify elusive cancer-related genetic changes and new biomarker targets across many cancer types. Our advanced cancer genome analysis helps researchers and biopharmaceutical partners accelerate new precision medicine development.

At Predicine, we are passionate about our people, technology, and creating a lasting impact in cancer research.
If you enjoy challenges, collaborating with others to solve complex problems, and the chance to see your work impact the millions of lives touched by cancer, we invite you to join us!
Responsibilities:

• While sitting on a product core team, oversee development and implementation of quality policies and procedures used to support the development cycle of a Companion Diagnostic from feasibility to product launch and maintenance, and transfer to sustaining manufacturing.
• Establish and maintain the IVD medical device design control process and the software design life cycle as it applies to the launch of product domestically and internationally.
• Oversee the creation of Design History File (DHF) and/or Technical Data File and their evolution during all phases of design control process.
• Assume responsibilities for the creation and maintenance of the risk management files associated with the individual DHF’s.
• Support internal and/or external audits.
• Together with the RA/QA team and other cross-functional teams, prepare Predicine lab(s) to be compliant with GCP, GLP, GMP and other applicable requirements prior to testing patient samples in a CDx clinical validation study.
• Support qualification and validation of supplier/vendors as needed.
• Train other departments on the design control and software design lifecycle requirements and processes.
• Demonstrate critical thinking, excellence, and speed when interacting with external partners and with regulatory authorities.
• Other tasks and projects as assigned.

*
Qualifications:*

• Bachelor's degree in a scientific field or applicable experience
• Minimum of 8 years’ experience effectively utilizing/implementing the quality management system and product development process
• Experienced in risk assessment compliant to EN ISO 14971 as it applies to the product development processes.
• Experienced with the implementation and execution of a software design lifecycle compliant to IEC 62304 Software Design Life Cycle
• Experienced with the implementation and execution of a design control process compliant to 820.30 (Design Control) and ISO 13485 (7.3 Design and Development)
• Experienced with creating and maintaining Design History Files/Technical Files
• Experienced as the Quality Representative on a product development core team
• Experience in managing external audits by regulatory bodies directed against the product development process for IVD medical devices and software.

• Excellent written and verbal communication skills
• High quality standards and attention to detail when authoring and reviewing documents
• Able to distill complex issues and clearly articulate solutions
• Demonstrated learning agility to quickly grasp new concepts and apply them in an entrepreneurial environment

We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.
Predicine is proud to be an equal opportunity employer committed to hiring a diverse and inclusive workforce. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Predicine does not accept unsolicited resumes from individual recruiters or third party recruiting agencies in response to job postings. We have in-house sourcing capacities. Please do not contact Hiring Managers.

Job Type: Full-time

Pay: $140,000.00 - $180,000.00 per year

Please Note :
www.bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, www.bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.