Associate Director, Design Control Quality Engineering

Job Description

Job Description

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!

Associate Director, Design Control Quality Engineering :

• Establish and maintain the IVD / IVDR medical device design control process and the software design life cycle as it applies to the launch of Class III domestically and internationally.
• 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.
• Create appropriate Design History File (DHF) documents and templates according to the regulatory guidelines and maintain DHF documents during all phases of design control process.
• Drive the design control process and provide guidance and support for DHF documents.
• Review the DHF and technical files for conformance to applicable requirements.
• Provide guidance and support for design verification / validation activities. Assess protocols and reports test robustness, traceability to requirements, and statistical sample sizes and quality of the test spec.
• Familiarity with GxP Regulations, Quality Management Systems (including e-QMS), EDMS, ISO Standards applicable to Medical Devices, CLSI Standards applicable to IVD Product Performance, FDA Regulatory pathways.

Assume responsibilities for the creation and maintenance of the risk management files associated with the individual DHF’s.

Draft Quality SOPs, as needed and as applicable, to Product Development lifecycle

• Review study protocols and reports for compliance with SOPs and regulations.
• Collaborate with Development, Laboratory Operations, Automation, IT / Software, and Computational Research / Bioinformatics to develop, verify and validate all new processes and methods.
• Lead and participate in dMFEA and pFMEA activities, maintain and update Risk Management documents.
• Support internal and / or external audits.
• Support 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 biology, engineering or healthcare field(s). Advanced degree (i.e. M.S. or Ph.D.) is preferred but not required
• CDx / PMA study management experience is desirable.
• Liquid biopsy testing, or next-generation sequencing (NGS) experience is desirable.
• Diagnostic IVD experience is required.
• 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), Current Good Manufacturing Practices (cGMPs), in addition to CLIA, CAP and NYSDOH guidelines.

• Experienced with creating and maintaining Design History Files / Technical Files.
• 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.

Our Opportunity :

We are not accepting third party resumes from recruiters, recruiting agencies or 3rd party vendors.

Candidate location : California / Remote

All full-time roles in the US come with a robust benefits package which includes healthcare, dental, and vision insurance.

Additional benefits include PTO, paid holidays and 401(k) retirement plan.

Salary : 140K-175K

The posted salary range is the estimated base salary range for this position. Should the level or location of the role change during the hiring process, the applicable salary range may be updated accordingly.

Compensation decisions are dependent on several factors including, but not limited to, an individual’s qualifications, location where the role is to be performed, internal equity, and alignment with market data.

We are proud to be an Equal Opportunity Employer. We are committed to ensuring a diverse and inclusive workplace environment, and welcome people of different backgrounds, experiences, abilities, and perspectives.

Inclusive collaboration benefits our employees, our community, and our patients, and is critical to our mission of changing the management of disease worldwide.

All qualified applicants are encouraged to apply, and will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, age, veteran status, disability or any other legally protected status.

We also consider qualified applicants regardless of criminal histories, consistent with applicable laws. All your information will be kept confidential according to EEO guidelines.

We require all Predicine employee's to be fully vaccinated and provide proof of vaccination on their first day of work.

All job offers are contingent upon successful completion of background verification.

Applicants must be legally authorized to work in the USA.