Employment Senior Quality Engineer

Company Overview

Auxogyn, Inc. is a privately held medical technology company focused on advancing women’s reproductive health by applying its novel scientific and clinical knowledge of early human developmental biology to the field of assisted reproduction and in vitro fertilization (IVF) procedures. Auxogyn’s first product in development combines a proprietary computational algorithm with developmental biology imaging capabilities to assess early embryo viability at the four-cell stage of development by identifying embryos that have the possibility of developing into a blastocyst. The company is funded by the leading life science venture firms Kleiner Perkins Caufield & Byers, TPG Biotechnology and Merck Serono Ventures.

Position Summary

Responsible for assessing and improving the Auxogyn Quality System. Support research and development activities, ensuring robust product designs, reviewing and approving design and process verifications and validations.

Major Duties and Responsibilities

  • Maintain and improve the quality system in accordance with FDA Quality System Regulation and ISO 13485 requirements
  • 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.
  • Contribute to Project Team efforts by determining design, product, and process quality requirements
  • Provide quality engineering interface with Engineering and Operations for nonconforming material investigation and disposition
  • Plans, coordinates, and executes activities concerned with development, application, and maintenance of quality processes and standards for manufacturing processes, materials, products, and facilitate design verification and process validation activities
  • Develop and initiate sampling procedures and statistical process control methods
  • Participate during FDA and Notified Body assessments
  • Support product complaint system and investigations
  • Perform trending analysis (Quality Metrics) on a routine basis
  • Perform other duties as assigned

Preferred Qualifications

Education and/or Job Experience

  • Bachelors 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
  • Some background and knowledge in medical device software

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
  • Deals with Ambiguity:
    • Can be flexible and adaptable in a complex, changing environment
    • Can comfortably handle risk uncertainty
  • Works Collaboratively:
    • Practice 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
  • Makes Quality Decisions:
    • Makes good decisions based on a mixture of analysis, wisdom, experience, and judgment
    • Seeks and encourages diverse input
    • Can challenge the status quo and think outside the box
    • Is sought out by others for advice and solutions
  • Is Respected as a Leader:
    • Leads and influences constituents with possible divergent interests to complete a common goal
    • Is recognized within the engineering community or related industry peers

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
  • Experience with performing internal and supplier assessments
  • Ability to effectively teach and train others
  • Strong knowledge of current versions of ISO 13485 and FDA Quality System Regulation
  • Proficient in computer skills (Microsoft Office products, word processing, excel, etc.)

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].

Back to Employment