EpicSciences, Inc. is developing novel diagnostics to personalize and advance thetreatment andmanagement of cancer. Epic’s mission is to enable the rapid and non-invasivedetection of genetic andmolecular changes in cancer throughout a patient’sjourney.The company was founded on apowerfulplatform to identify and characterize rare cells, includingcirculating tumor cells (CTCs).Ourtechnology helpsmatch patients to targeted therapies and monitor for drugresistance, so that the best treatment path canbe chosen at every clinicaldecision point.Today, we partner withleading pharmaceutical companies andmajor cancer centers around theworld.Epic’s goal is to commercializeour technology to increase thesuccess rate of cancer drugs in clinical trialsand improve patient outcomes by providing physicians real-timeinformation toguide 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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Principal Quality Assurance Software Engineer