Quality Engineer

Centerline Biomedical

Centerline Biomedical

Quality Assurance
Cleveland, OH, USA
Posted on Thursday, June 20, 2024
Position Summary
The Quality Engineer is an Exempt/Full-Time role responsible for maintaining and improving the quality system in accordance with the requirements of, as appropriate, the following standards: IS0 14971, ISO 13485:2016, MDSAP and FDA 21 CFR Part 820. This role supports supplier quality and monitoring primarily along with complaint/CAPA investigations, operations production and process controls, and product and service quality and the use of statistical techniques and other accepted quality principles. The Quality Engineer will also plan and execute activities concerned with the development, implementation, maintenance, and continuous improvement of Centerline’s quality systems.
Responsibilities/Duties
● Participate on cross-functional new product development teams with focus on the execution of quality plans and design transfer.
● May be trained as an auditor and perform quality audits.
● Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC and trend analysis.
● Lead and/or participate in process and product corrective actions and problem-solving activities.
● Constantly review the current quality system and recommend / implement improvements as needed.
● Review collected data to perform statistical analysis.
● Participate on projects focused on quality system, product quality and service quality improvement.
● Collect data and prepare reports on the trends of the quality system key performance metrics.
● Participate/support external and internal quality system audits.
● Supports development and implementation of methods for sampling, inspection, testing and evaluation of products.
● Completes Supplier Corrective Action Requests (SCARs) and communicates with suppliers in regards to non-conformances, supplier changes, etc.
● Acts as lead on assigned CAPAs to drive corrective actions and closure of CAPA within prescribed timelines.
● Performs and documents customer complaint investigations, performs root cause analysis and develops corrective and preventive actions. Works with customers to provide required technical support and information regarding the investigation.
● Instruct other employees in updated procedures, quality principles, effective corrective actions, and/or valid statistical techniques.
● Collaborate with other departments and facilities within the company on quality related issues.
● Maintain product integrity and quality through support of evaluation and disposition of nonconforming materials.
● Additional duties as assigned.
Minimum Qualifications, Education, and Experience Required
Education and Experience
• Bachelor's Degree in Engineering or related technical field required.
• 1-3+ years of combined Quality Engineering and/or Quality Systems experience.
• 1-3+ years of experience with medical device or other regulated industries preferred.
• 1-3+ years of experience working in an ISO certified environment required, ISO 13485:2016 preferred.
• Experience with EO sterilization validation preferred.
• Must have PC experience, as well as working familiarity of desktop applications including Excel, Word, and PowerPoint.
Abilities
• Excellent problem-solving skills
• Experience with root cause analysis tools
• Experience working on cross-functional teams and on own initiative
• Demonstrated excellent organizational, oral and written communications skills
• Commitment to learn new skills and tools as they become relevant
• Flexibility, self-starter, and ability to work in a diverse work environment dealing with multiple tasks with deadlines
Work Conditions:
Work is performed primarily in a standard office environment. Essential functions require sufficient physical ability and mobility to work in an office setting; to stand or sit for prolonged periods of time; to occasionally bend, kneel and reach; to lift, carry, push/pull light to moderate amounts of weight; to operate office equipment that may require fine motor coordination (i.e., use of a keyboard). Reasonable accommodations may be made when an employee has a qualified disability but can still perform the essential functions of the job (without creating an undue hardship).