Quality Engineer
Beachwood, OH
Competitive Pay & Benefits
As a Quality Engineer, you will be tasked with being a leader within the organization. Your focus will be to help drive continuous improvement activities to meet internal strategic goals along with increasing customer expectations. You will drive a culture of quality at the source where all associates assume ownership for the quality of their work, services, and products. You will work to develop and support statutory, regulatory and customer compliance, helping to sustain business growth and align with customer requirements.
Quality Engineer Responsibilities:
- Customer facing responsibilities which includes non-conformance review, driving root cause analysis and documenting corrective actions.
- Coordinating and communicating activities within Quality Assurance, as well as with other functional departments to meet customer on-time-delivery requirements.
- Daily 'hands-on' inspection layout responsibilities to assist with in-process, receiving and final inspection.
- Become resident expert on all aspects of gaging, including gage selection, procurement, calibration, maintenance, and training of operators / inspectors in how to use gages/equipment.
- Assist in maintaining the ISO9001 quality management system and support the company’s initiative to obtain AS9100 certification.
- Assist in collecting, compiling, and generating metrics for operations and management review meetings.
- Participate in the development of Control/Inspection Plans, AS9102 FAIR and IQ/OQ/PQ packages.
- Assist in performing Supplier Audits/Surveys and driving closure to Supplier Corrective Action Requests (SCARs).
- Independently coordinate, collaborate, and communicate quality solutions with Engineering, Manufacturing, Suppliers, Maintenance and Operations to ensure product quality and problem resolution.
- Assist in identifying & driving continuous improvement opportunities.
Quality Engineer Requirements:
- Bachelor's degree in engineering or related degree.
- 0-2 years of experience in a high-precision manufacturing environment.
- Computer skills including Microsoft Office (Word, Excel) and statistical analysis (Minitab or equivalent).
- Strong verbal, customer-facing, and written communication skills.
- The ability to effectively communicate (verbally and written) and delegate while maintaining forward motion on key deliverables.
- Interpersonal skills to motivate and influence others, including those not under their direct supervision.
Preferred Qualifications
- CMM programming experience, using PC-DMIS and PolyWorks.
- ASQ certification (CQE, CRE, etc.) is considered a plus.
- Solidworks/CAD/CAM experience and education or exposure to Lean Six Sigma.
- Working knowledge of Process Validation for medical device industry (IQ/OQ/PQ), CAPA (corrective and preventative action), and AIAG PPAP requirements.
- Demonstrated knowledge of multiple functional technologies/processes related to product manufacturing including turning and molding.
- Demonstrated abilities of problem solving, systems thinking, project management, and team building.
