Quality Engineer
Not Disclosed•Full-TimeOn-site
location_on5537, Turnberry Lane, Aberdeen West, Aberdeen, Highland Heights, Cuyahoga County, Ohio, 44143, United States
About Norman Noble
Norman Noble is a renowned, privately-held contract manufacturer of life-sustaining medical devices dedicated to improving and saving lives. For nearly 80 years, our reputation for excellence and outstanding team have provided exceptional service to customers worldwide. Our state-of-the-art facilities support innovative solutions where we manufacture, finish, and inspect medical device implants.
About the Role
The Quality Engineer serves as a critical bridge between internal teams, suppliers, and customers. In this role, you will analyze data, develop solutions, and make strategic decisions to support and enhance manufacturing processes. You will lead and manage multiple customer projects focused on process improvement, collaborating directly with clients on process change approvals. Your work will ensure the maintenance and control of our quality management system, including quality system documents, records, device history records, and final product release.
You will partner with Customers, Sales, and Engineering on validation and quality planning activities for new or existing programs, performing validation activities as part of supplier qualifications. Additionally, you will review drawings to recommend inspection and gauging methodologies and participate in customer, supplier, and regulatory audits as part of the Supplier Quality Team to evaluate and qualify new suppliers.
Why Work at Norman Noble?
Our employees enjoy an entrepreneurial work experience where every contribution is important and visible. Our manufacturing facilities are state-of-the-art, clean, and lab-like, providing the tools and resources needed to succeed. Continuous growth is fostered through collaborative project work, high-tech problem-solving, and interaction with customers and key internal stakeholders.
Equal Opportunity Employer
Norman Noble, Inc. is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of age, gender, gender identity or expression, sexual orientation, marital status, race, color, ethnicity, religion or creed, national origin, citizenship, disability, veteran status, political affiliation, or any protected characteristics as required by federal, state, or local law. We are committed to the inclusion of qualified individuals, including those with disabilities who require reasonable accommodation to perform essential job functions.
Work location
Work model: On-site
5537, Turnberry Lane, Aberdeen West, Aberdeen, Highland Heights, Cuyahoga County, Ohio, 44143, United States
Highland Heights, Ohio
Key Responsibilities
- check_circleLead and manage multiple customer projects aimed at process improvement
- check_circleCollaborate with customers on process change approvals
- check_circleManage quality system processes through data analysis and project completion
- check_circleSupport maintenance of quality management system documents and device history records
- check_circleAssess and evaluate existing suppliers for quality and performance
- check_circleReview drawings and recommend inspection and gauging methodologies
- check_circleCoordinate validation and quality planning activities for new or existing programs
- check_circleParticipate in customer, supplier, and regulatory audits
Requirements
- verifiedTwo or more years hands-on quality engineering experience in med device, aerospace, or automotive manufacturing
- verifiedBachelor's degree in an Engineering discipline required (biomedical, chemical, materials, or mechanical preferred)
- verifiedExperience leading and executing CAPAs
- verifiedExperience managing multiple customer and/or supplier projects
- verifiedUnderstanding of SPC, FMEA, DOE, inspection methods and equipment required
- verifiedExperience preparing, coordinating and executing validation activities including IQ, OQ, PQ, and MSV
- verifiedStrong working knowledge of ISO 9001, ISO 13485, and FDA QMSR
- verifiedASQ CQT, CQA and/or CQE certification is a plus
Nice to Have
Bachelor's degree in biomedical, chemical, materials, or mechanical engineering. Experience with maintaining and monitoring controlled environments (cleanroom). ASQ CQT, CQA, and/or CQE certification.
Similar Job Opportunities
Skills, education and keywords
Skills: Capa, SPC, Fmea, Doe, Iq, Oq, PQ, MSV, Iso 9001, Iso 13485.
Education: Bachelor's degree in an Engineering discipline required.
Frequently asked questions about Quality Engineer at Norman Noble, Inc.
What does a Quality Engineer at Norman Noble, Inc. do?expand_more
In this Quality Engineer at Norman Noble, Inc. role, you will lead and manage multiple customer projects aimed at process improvement; collaborate with customers on process change approvals; manage quality system processes through data analysis and project completion; and support maintenance of quality management system documents and device history records.
What are the requirements for this Quality Engineer role?expand_more
To qualify for the Quality Engineer at Norman Noble, Inc. position, applicants should have: Two or more years hands-on quality engineering experience in med device, aerospace, or automotive manufacturing; Bachelor's degree in an Engineering discipline required (biomedical, chemical, materials, or mechanical preferred); Experience leading and executing CAPAs; Experience managing multiple customer and/or supplier projects; Understanding of SPC, FMEA, DOE, inspection methods and equipment required; and Experience preparing, coordinating and executing validation activities including IQ, OQ, PQ, and MSV.
Where is the Quality Engineer role at Norman Noble, Inc. located?expand_more
Quality Engineer at Norman Noble, Inc. is based in 5537, Turnberry Lane, Aberdeen West, Aberdeen, Highland Heights, Cuyahoga County, Ohio, 44143, United States. This is a on-site role.
Is this Quality Engineer job remote, hybrid, or on-site?expand_more
Norman Noble, Inc. has listed this Quality Engineer role as on-site.
How much experience is required for this Quality Engineer role?expand_more
Candidates for Quality Engineer at Norman Noble, Inc. should have mid level.
What skills do you need for the Quality Engineer role at Norman Noble, Inc.?expand_more
Key skills for Quality Engineer at Norman Noble, Inc. include Capa; SPC; Fmea; Doe; Iq; Oq; PQ; and MSV.
What education is required for Quality Engineer at Norman Noble, Inc.?expand_more
Educational requirements for this role: Bachelor's degree in an Engineering discipline required.
What category does the Quality Engineer role belong to?expand_more
Quality Engineer at Norman Noble, Inc. is part of the engineering job category on Recrutus.
About Norman Noble, Inc.
Norman Noble, Inc., headquartered in Highland Heights, Ohio, operates within the medical equipment manufacturing sector as a specialized contract manufacturer for medical devices and implants. For eight decades, the organization has provided microprecision contract manufacturing services, focusing on micromachining exotic materials into complex geometries with dimensional tolerances of plus or minus .0001 inches. The company serves clients requiring advanced solutions for medical device components, supporting projects from initial prototype stages through full market production.
The firm is recognized for its technological capabilities within the medtech industry, employing a vertically integrated approach that includes proprietary machining and finishing processes. It holds a distinction as the largest contract manufacturer of Nitinol implants globally, offering design for manufacturability services, laser machining, shape setting, and electropolishing for super-elastic and shape-memory materials. Additional specialized operations include stent manufacturing and orthopedic implant manufacturing, supported by cleanroom assembly and packaging facilities.
To ensure precision and efficiency, Norman Noble utilizes five dedicated, independent Process Development Centers separate from production areas. These facilities enable engineers to validate manufacturing processes and develop custom workflows. The organization leverages DSC testing and SEM analysis to support the production of Nitinol implants, ensuring that finished products meet exact drawing specifications and rigorous medical standards.
Browse more roles: All Norman Noble, Inc. jobs, engineering jobs on Recrutus.