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Senior Quality Engineer

4 months ago

Morrisville, United States KNOW Bio, LLC Full time

About KNOW Bio

KNOW Bio, LLC is a life science company redefining the standards of care in a number of diseases and medical conditions. Utilizing our extensive catalog of intellectual property in the fields of Nitric Oxide and precision light therapy, we develop unique treatments to revolutionize the standard of care for many indications.


Position Summary

This position is a contract position. We are searching for a a hands-on motivated individual who will be responsible for supporting post market quality assurance activities and limited support for development of new products and design changes to ensure design control compliance.

Reports to Vice President Quality, Regulatory and Clinical Affairs. This is not a software QE position and software quality should not apply.


Key Responsibilities:

  • Investigate and document product complaints. Assist engineering and customer support to ensure complaints are closed within designated time periods.
  • Review device history records/batch records and perform finished device product release. Work with suppliers to resolve discrepancies. Serve as the quality liaison to contract manufacturers.
  • Perform component or finished device inspections or guide inspectors during inspection. Develop inspection specifications, select inspection tools, and train/guide others in proper sampling, inspection, and data analysis techniques. Develop and document test protocols and summary reports as needed.
  • Perform other analysis and duties as may be requested by members of management.
  • Plan and execute duties in such a manner as to ensure company will maintain developmental timelines without sacrificing quality standards. In the event its probable timelines will slip, inform subsidiary and KNOW Bio management.
  • Performs duties in most efficient (balancing cost and effectiveness) manner possible.


Required Qualifications:

  • ISO 13485 and FDA (Food and Drug Administration) QSR experience required.
  • Experience with durable electromechanical medical devices.
  • Experience with equipment calibration and equipment/process validation for medical device manufacturing.
  • Experience in supplier management.
  • Must have a valid passport for international travel.


Education/Experience:

  • Requires a bachelor's degree in mechanical or biomedical engineering.
  • At least 10 years of experience in the medical devices field in areas related to medical device manufacturing and post market quality operations.
  • Familiar with a variety of the field's concepts, practices, procedures, and regulations.

Skills

  • Honest, flexible, dependable, self-motivated team player with the ability to work autonomously.
  • Present a positive attitude to create and maintain productive working relationships with fellow employees and vendors.
  • Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills and ability to interact with all levels of management.
  • Proven ability to influence at all levels across functions.
  • Capable of motivating people, instilling accountability, and achieving results.
  • Excellent oral and written communication skills with senior management and external parties.
  • Effectively prioritizes workload and manages time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced, interrupt-driven environment.


Physical Demands and Work Environment:

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.


In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds. There will be an occasional requirement to work outside of normal business hours, consistent with other Manager-level positions. Up to 25% travel may be required.


KNOW Bio maintains a drug-free workplace and performs pre-employment and employment substance abuse testing and background verification checks.


KNOW Bio is an equal opportunity employer and does not discriminate against any employee or applicant for employment. We encourage and foster diversity in the workplace.