Sr. Quality Engineer

$95,000 - $115,000/Yr

Cirtec - Sturtevant, WI

Full-time - Mid Level

Sturtevant, WI

Publishing Industries

About the position

The Senior Quality Engineer at Cirtec Medical is responsible for developing, establishing, and maintaining quality engineering methodologies, systems, and practices that meet customer and regulatory requirements. This role focuses on providing quality engineering support to new product development, operations, and quality systems, while also serving as a Quality representative to enhance awareness and communication on quality initiatives to support corporate goals.

Responsibilities

• Provide Quality Engineering support for engineering product development or sustained manufacturing.
• Provide Quality Project Management support for product transfers from development to validation to production.
• Act as Verification/Validation System Owner responsible for the development and management of the verification/validation master plan.
• Develop and maintain Standard Operating Procedures.
• Create and maintain project Quality Plans for assigned projects.
• Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development.
• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols.
• Provide Quality Engineering support for engineering/manufacturing.
• Act as CAPA (Corrective and Preventative Action) system owner or support for corrective action system and procedures.
• Interact with customers and suppliers to resolve CAPA and complaint investigations.
• Provide Quality Support for the disposition of material via NCRs.
• Support supplier quality activities including vendor approval and performance data assessment.
• Review and document procedure changes for quality requirements and compliance.
• Develop quality systems and procedures as needed.
• Support third party audits, customer audits, and internal audits.
• Implement continuous improvement initiatives.
• Develop and maintain production quality control plans.
• Initiate and maintain SPC (Statistical Process Control) for production processes.
• Lead or support FMEA (Failure Modes & Effects Analysis) and DOE (Design of Experiment) as applicable.
• May serve as backup to Quality Manager.
• Comply with company, quality, and safety standards, policies, and procedures.

Requirements

• A Bachelor's degree in a STEM engineering discipline preferred and 5 years of experience required, or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes, preferably in medical devices.
• Fluency in computer systems for data analysis, specifically Microsoft Office.
• Excellent verbal communication, organizational, and management skills.
• Training or equivalent experience in Microsoft Word, Excel, PowerPoint, and Access; Minitab experience desirable.
• Ability to read, write, and speak fluent English.
• Capability to implement quality programs, interpret collected data, and present data to management for continuous improvement.
• Ability to analyze and process information, promote process improvement, develop standards, manage processes, and support innovation.

Benefits

• Training and career development
• Healthcare and well-being programs including medical, dental, vision, wellness, and occupational health programs
• Paid Time Off
• 401(k) retirement savings with a company match