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Senior Quality Engineer

Employer
Katalyst Healthcares & Life Sciences
Location
Morrisville, NC
Closing date
Jul 22, 2024

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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 the 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 the most efficient (balancing cost and effectiveness) manner possible.

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.

Requirements:

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.

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.

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