Schedule: Monday-Thursday, 3:30 PM-1:30 AM

Position Summary:

The Senior Quality Engineer (2nd shift) provides hands-on quality engineering support for the manufacturing of medical device components, with primary responsibility for supporting 2nd shift production operations from quality perspective. Working both on the manufacturing floor and in office, this role serves as the technical quality lead for assigned production lines, ensuring process stability, resolving quality issues, implementing corrective actions, and driving continuous improvement.

This role collaborates cross-functionally to meet production and quality objectives within a contract manufacturing environment.

Key Responsibilities:

• Provide Quality Engineering support for engineering product development, or sustained manufacturing.
• Provide Quality Project Management support as needed for product transfers from development to validation to production.
• Verification/Validation System Owner responsible for the development and management of the verification/validation master plan along with the verification/validation determination.
• Develop and maintain Standard Operating Procedures.
• Develop and maintain project Quality Plans for assigned projects.
• Develop protocols, perform statistical analyses, and write reports for validations and formal product/process development, which requires quality-engineering involvement.
• Support the development and implementation of IQ (Installation Qualification) and OQ (Operational Qualification) protocols to ensure compliance with the Quality System.
• CAPA (Corrective and Preventative Action) system owner or support responsible for the support of the 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 maintaining and assessing vendor performance data (i.e. SCAR/on time).
• Review and document procedure changes for quality requirements and compliance with the quality system.
• Develop quality systems and procedures as needed.
• Audit support for third party audits, customer audits and internal audits.
• Support the implementation of 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.

Must Have:

• A Bachelor's degree in a STEM discipline and 5 years of quality engineering experience required.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes.
• Must be fluent in use of computer systems for the analysis of data, specifically Microsoft Office.
• Must be able to implement quality programs, interpret the collected data, and present the data to management to drive continuous improvement.
• Must be able to analyze and process information; promote Process Improvement, Developing Standards, Managing Processes, Manufacturing Methods, and Procedures; and Support Innovation.
• Demonstrated ability to perform root cause analysis and implement effective corrective actions.
• Working knowledge of ISO 13485 and GMP requirements.
• Experience with manufacturing process documentation and engineering change management.
• Strong verbal and written communication skills.
• Strong problem-solving skills with a hands-on, detail-oriented approach.
• Experience with MES and ERP systems required.

Good to have:

• Medical device experience preferred.
• Minitab experience desirable
• Experience with Lean manufacturing principles and continuous improvement methodologies; Six Sigma certification a plus.
• Experience with single-piece flow manufacturing is a plus.

Salary Range: $100,000-$130,000

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec's goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.