Quality Engineer
Location: Mentor, Ohio (Onsite)
Structure: Contract-to-HireAbout the ClientOur 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.
About the Role:
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 & Responsibilities
- 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.
- Collaborate with other departments and facilities on quality-related issues.
Required:
Bachelor’s degree in Engineering.
Minimum of 3 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
Minimum of 3 years of experience working in an ISO certified environment.
Experience with medical device or other regulated industries.
Preferred:
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.Knowledge of TrackWise, Windchill PLM, or similar systems.
Other:
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.
Adapts well to change and participates in change initiatives.
About Us:
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. We are a certified partner of leading platforms, including Salesforce, AWS, Microsoft, and Google Cloud, enabling us to deliver scalable, end-to-end technology solutions. With a growing national footprint, Brooksource is redefining expectations in IT consulting, engineering services, and technology workforce solutions.
EEO Statement:
Brooksource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.
Benefits & Perks:
Brooksource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs. We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays. We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.
Pay Disclaimer:
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.
