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Brooksource · Mentor
Quality Engineer
Mentor, Ohio (Onsite)
Structure:
Contract-to-Hire
About the Client
Our client is a leading global provider of products and services that support patient care with an emphasis on infection prevention. They help their customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
The Quality Engineer at our client's Mentor, OH location is responsible for maintaining and improving the quality system in accordance with ISO 9001, ISO 13485, MDSAP, FDA 21 CFR Part 820/211, EU MDR, and other applicable standards. The role supports complaint and CAPA investigations, supplier quality improvement, production and process controls, and product and service quality improvement using statistical techniques and other accepted quality principles.
This position is onsite in Mentor, OH, Monday through Friday, and works closely with operations, engineering, and other quality team members to carry out the development, implementation, maintenance, and continuous improvement of our client's quality systems.
Job Description – Duties &
Participate on cross-functional new product development teams with a focus on product/service quality and quality system compliance.
Develop and implement statistically valid sampling plans, designed experiments, capability studies, SPC, and trend analysis in support of product and service improvements.
Initiate and participate in process and product corrective actions and problem-solving activities, including complaint and CAPA investigations.
Review collected data, perform statistical analysis, and recommend process and product changes to improve quality.
Maintain product integrity and quality through the evaluation and disposition of nonconforming materials and processes.
Support supplier quality improvement, including supplier audits and corrective actions.
Perform and support internal and external quality system audits and provide guidance on corrective actions.
Update and establish documented work instructions as needed.
Monitor and report on quality performance metrics.
Instruct other employees in quality principles, effective corrective actions, and valid statistical techniques.
Bachelor’s degree in Engineering.
Minimum of 3 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
ASQ certification (Certified Quality Engineer and/or Certified Quality Auditor).
Quality Management System Regulation (QMSR) certification or familiarity with QMSR/GMP regulations.
Knowledge of ISO 13485.
Excellent problem-solving skills; identifies technical problems and offers practical solutions.
Continuous improvement mindset that embraces new ideas and ways of approaching a project.
Maintains strong cross-functional relationships to solve problems collaboratively.
Communicates through facts and data and produces clear, high-quality technical documentation.
Completes assigned tasks on time with minimal supervision by following standard work processes.
At Brooksource, relationships are the foundation of everything we do. Since 2000, we’ve built lasting partnerships with clients, consultants, and internal teams to deliver an exceptional experience across every engagement. As a trusted IT and Engineering services provider, Brooksource supports Fortune 500 organizations through Experience-Driven Staffing, Professional Services, and Elevate, our proprietary Workforce Transformation program. Whether you’re hiring for software development, cloud computing, cybersecurity, data analytics, or enterprise IT, our customized staffing solutions are designed to align with your company’s unique goals, culture, and technology stack. We offer flexible hiring models, including contract, contract-to-hire, and direct placement to meet your evolving business needs.
The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.
Details
| Company | Brooksource |
| Location | Mentor |
| Type | FULL TIME |
| Niche | Full-time |