3 Jobs in Morrisville, NC
Katalyst Healthcares & Life Sciences is Hiring a Senior Quality Engineer Near Morrisville, NC
- 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.
Job Summary
Contractor
$77k-92k (estimate)
06/07/2024
07/05/2024
katalysthls.com
South Plainfield, NJ
<25
Related Companies
The job skills required for Senior Quality Engineer include Problem Solving, ISO, Written Communication, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Senior Quality Engineer. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Senior Quality Engineer. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Senior Quality Engineer positions, which can be used as a reference in future career path planning. As a Senior Quality Engineer, it can be promoted into senior positions as a Quality Assurance Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Senior Quality Engineer. You can explore the career advancement for a Senior Quality Engineer below and select your interested title to get hiring information.
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