Senior Quality Engineer - Katalyst Healthcares & Life Sciences
Morrisville, NC 28115
About the Job
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.
- 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.
Source : Katalyst Healthcares & Life Sciences