Quality Engineer

Company Overview

Auxogyn is a privately held company and leader in reproductive health. We provide novel scientific and clinically validated solutions to IVF clinicians and their patients by translating scientific discoveries in early embryo development into clinical tools that improve patient outcome. The company’s flagship product, the Eeva Test, delivers objective information regarding embryo development that IVF clinicians and patients can use to make important treatment decisions.

Auxogyn’s Eeva System is the first and only non-invasive device FDA has cleared to date to aid in embryo selection. Auxogyn received FDA clearance for the Eeva System in June, 2014. The Eeva System also received the CE mark in July 2012, and it is currently available for use in selected countries in the EU and Canada.

Auxogyn is privately held and funded by Kleiner Perkins Caufield & Byers, Merck Serono Ventures, SR One and TPG Biotech. Follow the company on Twitter @Auxogyn.

Position Summary

Responsible for assessing and improving the Auxogyn Quality System with primary focus on IQC, NCMR, Complaints, Calibration and PM. Support on-going production activities, ensuring appropriate documentation and product release.

Major Duties and Responsibilities

  • Support quality control activities, including, but not limited to: IQC, in-process and finished product testing and release, Risk Management activities (FMEA, hazard analysis), IQ/OQ/PQ, etc.
  • Provide quality engineering interface with Engineering and Operations for nonconforming material investigation and disposition
  • IQC:
    • Develops and evaluate new testing and inspection methods for products and raw materials
    • Coordinate with manufacturing, purchasing, and receiving to ensure proper prioritization of inspection tasks and proper handling of nonconforming materials
    • Manage QA inspector. Train new inspectors and conduct recurrent training as required
    • Promptly resolve quality issues as they are identified during IQC process with the supplier
  • Complaint Process:
    • Identify the opportunities to improve the complaint process, including returned product and decontamination processes
    • Manage the entire Complaint process in accordance with established SOPs – responsible for co-ordination of receipt, investigation and resolution of customer complaints. Facilitate all complaint investigation activities with cross functional team members and preparation of complaint investigation reports, including root cause analysis and resolution of complaints. Interact with appropriate stakeholders including but not limited to customers, medical professionals and field staff to obtain information pertinent to investigations. Prepare response to customers as necessary. Work closely with RA to determine reportability to the FDA and other regulatory agencies
    • Initiate CAPAs related to product complaints as appropriate
    • Ensure that complaints are managed from start to finish consistent with business objectives and in compliance with regulatory requirements such as Food and Drug Administration (FDA), International Standards Organization (ISO), Quality System Requirements (QSR) and other regulatory guidelines
    • Analyze and trend complaint data to identify new and/or systemic issues and notify management of events requiring immediate action
  • Manage and maintain the calibration and preventive maintenance program
  • Monitor key quality indicators and perform trend analysis (Quality Metrics) on a routine basis
  • Perform other duties as assigned

Preferred Qualifications

Education and/or Job Experience

  • Bachelor’s Degree in Engineering
  • 7-10 years of experience in medical device quality assurance engineering
  • Must understand, follow and comply with regulatory requirements as applicable to various processes. An understanding of FDA Quality System Regulations and ISO Standards (ISO 13485 and ISO 14971) is required
  • Experience and knowledge in medical device software

Special Skills, Abilities, and Requirements

  • Must have strong analytical, statistical, problem solving, communication, and interpersonal skills
  • Effective root-cause defect analysis skills
  • Detail oriented with excellent team oriented organizational skills
  • Strong knowledge of regulatory requirements specifically those applicable to complaint handling, investigations and documentation (21 CFR Part 803, MEDDEV 2 12-1 Vigilance System).
  • Strong knowledge of current versions of ISO 13485 and FDA Quality System Regulation
  • Proficient in computer skills (Microsoft Office products, word processing, excel, etc.)

Demonstrated Personal Characteristics

Candidate must be driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others. Essential attributes of the successful candidate is one who:

  • Is Action Oriented:
    • Motivated by results
    • Full of energy when faced with challenges
    • Able to make and implement tough decisions
    • “Proactive” as opposed to “reactive”
  • Deals with Ambiguity:
    • Can be flexible and adaptable in a complex, changing environment
    • Can comfortably handle risk and uncertainty
  • Works Collaboratively:
    • Practices attentive and active listening
    • Has the patience to hear people out and to search for constructive input
  • Exemplifies Interpersonal Savvy and Integrity:
    • Relates well to all kinds of people—both inside and outside the company
    • Builds constructive and effective relationships
    • Uses diplomacy and tact
    • Adheres to an appropriate set of core values and beliefs
    • Always acts with uncompromising integrity

We offer a competitive compensation package including health insurance, stock options and a challenging work environment. We are an equal opportunity employer.

Qualified candidates please send your resume to [email protected].

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