Senior Quality Engineer

at  Katalyst Healthcares Life Sciences

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.

• 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