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 full time, contract, on locations position responsible for supporting post market quality assurance activities and limited support for development of new products and design changes to ensure design control compliance.

This position will assist in investigating and documenting product investigations resulting from customer complaints, including review of risk analyses and labeling, and documenting and closing complaints.

This position is responsible for supporting sustaining engineering of products via supplier support in the form of supplier evaluations, review and disposition of non-conforming material and deviations, continued equipment/process support, and product change support. The Senior QE will support supply chain via supplier audits, supplier monitoring, supplier CAPA, etc.

Special projects may include: (1) Planning and validating numerous computer software systems, (2) creating a digital hierarchy for management of design history files in the EDMS, (3) organizining product design change histories to support FDA compliance.

Principal Duties and 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 contract manufacturers 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 supplier audits and supplier qualifications and document and maintain supplier files.

Develop and execute equipment, including computer software systems, and process validations for internal company equipment/processes including internally designed equipment allocated and transferred to contract manufacturers.

Review and approve product documentation as the quality representative including component specifications, bills of materials, and design changes.

Support the development of device history records and device master records, and support the overall transfer of products and product modifications from R&D into manufacturing.

Assist R&D in change management.

Perform trends analysis of quality system data for management review such as non-conforming material, deviations, CAPA, supplier quality, etc.

Assist in corrections to the quality system including investigations and closure of Corrective and Preventive Actions.

All Other Essential Duties as directed.

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/software validation for medical device manufacturing.
• Experience in supplier management.
• Experience in risk management.
• Experience in product investigations/analysis.
• Must be able to lift at least 25 lbs.
• Must have valid driver’s license.
• Must have a valid passport for international travel. Must be available to travel up to 25% including international trips of 1-2 weeks in length.

Education/Experience:

• Requires a bachelor's degree or above in mechanical, electrical, 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. Some travel may be required (5-10%).

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.