Sr. Quality Engineer - Manufacturing

Viant Medical•Wheeling, IL

45d

About The Position

We are seeking a highly experienced and motivated Senior Quality Engineer to join our team. This role is critical in ensuring product quality and regulatory compliance throughout the design and manufacturing process. The ideal candidate will bring deep expertise in quality systems, process improvement, and cross-functional collaboration within a regulated industry, preferably medical devices.

Requirements

Bachelor's degree in Engineering (Mechanical Engineering preferred) or a related discipline.
Minimum 7+ years of Quality Assurance experience in a regulated manufacturing environment, preferably medical devices or other regulated industry.
Strong knowledge of root cause analysis, DOE, statistics, lean manufacturing, risk management, and Six Sigma methodologies.
Proficient in Microsoft Office and Minitab.
Excellent interpersonal, written, and verbal communication skills.
Proven ability to work independently and manage multiple priorities.
Demonstrated success in driving continuous improvement and leading cross-functional teams.

Nice To Haves

CQE, CRE, CQA, Six Sigma Green or Black Belt
Familiarity with metals processing and Toyota Production System is a plus.

Responsibilities

Adhere to company Core Beliefs and all safety and quality requirements, including, but not limited to company Quality Management System (QMS); Environmental, Health & Safety; company policies, procedures, and work instructions; and other relevant regulatory requirements.
Support regulatory and agency inspections, audits, investigations, and inquiries regarding the control and assessment of product design and manufacturing quality.
Monitor manufacturing of assigned products, ensuring compliance with DMR and quality system requirements, and ensure complete and correct Device History Records are maintained.
Identify, prioritize, and implement product and process improvement initiatives.
Review the adequacy and correctness of changes to Bills of Material (BOM's), Assembly Procedures, Drawings, Component Specification, FMEAs, Control Plans, etc.
Generate and lead the completion of protocols and reports for product, process, and test method validations.
Partner with Manufacturing Engineers to review processes for new and existing products and coordinate process validations and capability studies. Recommend process monitoring devices where required and/or appropriate.
Develop various inspection techniques and procedures to ensure product integrity to design specifications. Write and implement Incoming, In-Process, and Final Inspection procedures.
Ensure that the disposition of non-conforming materials comply with all relevant requirements and ensure that appropriate corrective actions are implemented to prevent recurrence.
Lead complaint investigations and manage appropriate remediation activities.
Review quality data for potential CAPA's, including analyses of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root cause analyses.
Assist with product transfers.
Work with suppliers, management, engineers, and manufacturing associates in the resolution of quality problems. Also, assist each of these groups with capability studies and the application of statistical quality control, including Cpk, DOE, Hypothesis Testing, etc.
Provide technical support and direct the work of Quality Inspectors, Quality Technicians, Training Specialists, and/or other Quality Engineers as needed.