Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic’s mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient’s journey.  The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells (CTCs).  Our technology helps match patients to targeted therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point.  Today, we partner with leading pharmaceutical companies and major cancer centers around the world.  Epic’s goal is to commercialize our technology to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices.

SUMMARY:

The Quality Assurance (QA) Software Engineer is responsible for providing compliance and regulatory support to the organization. The QA Software Engineer will work closely with IT, Platform Technology, and Data Science departments to provide guidance and direction to meet the applicable requirements in IEC 62394, FDA regulations and other ISO standards. This position will ensure Epic software is developed, documented, validated, released, and maintained appropriate to its risk level. In addition, this position will support all aspects of Quality as needed. This person will be organized, self-motivated and have strong oral and written communication skills as they will work closely with internal customers to draft or revise documents and procedures.

ELEMENTS:

Education/Experience:   BS or higher in a related field, 10 years of experience in a quality-regulated environment (ex:  CLIA, FDA, or ISO lab) and a minimum of 5 years of software development/quality engineering experience.  Demonstrated mastery of 21 CFR Part 820, 21 CFR Part 11, IEC 62304, ISO 14971, and ISO 13485.  Current ASQ-CSQE is a plus. 

Communication Skill : Clear and accurate written and verbal communication.  Works effectively with both internal and external audiences to analyze, interpret, and summarize data both orally and in writing.  Possess ability to write detailed protocols and procedures and SOP’s, and draft details reports for communication of progress and results.  

Interpersonal Skill: Works effectively both as an independent contributor, a team member, and a champion for quality; can manage relationships with internal and external customers effectively.   

Judgment: Ability to design and implement quality-related qualitative and quantitative reviews and analyses; prioritize work and meet multiple deadlines, ability to work with significant independence.  Effective time management skills.

Execution: Demonstrated effectiveness at providing practical guidance, design control, and risk management expertise to facilitate project management.  

  ESSENTIAL FUNCTIONS: 

• Support software system testing and design verification to appropriate standards

• Evaluate and establish risk management standards to support project management goals in line with QA targets

• Support non-product validation efforts including IQ, OQ, and PQ as necessary

• Support non-conforming product investigations, assess impact, draft CAPA’s as necessary

  ADDITIONAL DUTIES:

  May perform additional duties as assigned or directed by management from time to time.

  REQUIRED COMPETENCIES: 

• Performance Orientation – Is driven by personal performance; achieves all objectives detailed in scorecards and comfortable with quantifiable assessments.

• Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.

• Competitive – Dedicated to a competitive spirit that supports Epic Sciences’ goal to be the premier CTC technology in the industry. 

• Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.

• Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.

• Confidence - Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.

  PHYSICAL DEMANDS: 

  The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. 

• The employee must occasionally lift and/or move up to 25 pounds.

• Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

• Transition from standing and sitting often. 

  WORK ENVIRONMENT: 

  The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• General office environment. Daily exposure to PCs and networks. 

• The noise level in the work environment is usually moderate.

  Disclaimer:

  The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. 

  Epic Sciences is an Equal Opportunity Employer and committed to the principle of diversity

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