Manufacturing Quality Engineer

Viant Medical Inc.; Wheeling, Northern (IL, KY); Hybrid; USD 95,000 - 115,000; Full time

Benefits offered by this job

Medical, Dental, Vision

PTO 136 hours & 10 holidays

Company-paid life insurance

401k plan

Pet Insurance

Home Ownership

Tuition Reimbursement

Job summary

Viant Medical Inc. seeks a Senior Quality Engineer to ensure product quality and regulatory compliance throughout design and manufacturing of medical device components and finished products.

The role emphasizes QMS, process improvement, and cross-functional collaboration within a regulated environment. The ideal candidate brings deep expertise in quality systems and statistical methods, with a track record of leading CAPAs, inspections, and supplier quality initiatives.

Qualifications

• Bachelor's degree in Engineering or related discipline required.
• Minimum 7+ years of QA experience in regulated manufacturing environment.
• Experience with medical devices or regulated industry preferred.
• Strong knowledge of quality systems and regulatory compliance.

Responsibilities

• Adhere to QMS and safety/quality requirements across design and manufacturing.
• Support regulatory inspections, audits, investigations, and inquiries.
• Monitor manufacturing for compliance with DMR and QA systems; maintain device history records.
• Identify and drive product and process improvement initiatives.
• Review changes to BOMs, assembly procedures, drawings, specs, FMEAs, and control plans.
• Lead protocols and reports for product/process/test method validations.
• Collaborate with Manufacturing Engineers on process validations and capability studies.
• Develop inspection techniques and write/implement Incoming, In-Process, and Final Inspection procedures.
• Ensure proper disposition of non-conforming materials and execute corrective actions.
• Lead complaint investigations and remediation activities.
• Review QA data for CAPA candidates and root-cause analyses.
• Assist with product transfers and supplier quality improvements.
• Support SPC, DOE, Hypothesis Testing in quality problems.

Skills

Root cause analysis

DOE

Statistics

Lean manufacturing

Risk management

Six Sigma

Microsoft Office

Minitab

Education

Bachelor’s degree in Engineering (Mechanical preferred)

Tools

Minitab

Job description

Manufacturing Quality Engineer

About the Site:

Our Wheeling facility combines precision machining and assembly capabilities to deliver high-quality medical device components and finished products.

We offer market competitive compensation. Potential salary range for this role is $95k-$115k. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. Onsite daily.

Benefits:

• Medical, Dental, and Vision benefits, effective date of hire
• 136 Hours PTO (prorated based on hire date) & 10 paid Holidays
• Company-paid life insurance
• 401k plan
• Pet Insurance
• Home Ownership
• Tuition Reimbursement

About the Role

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.

What you'll do: Key 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.

Qualifications

Education:

• Bachelor’s degree in Engineering (Mechanical Engineering preferred) or a related discipline.

Experience:

• Minimum 7+ years of Quality Assurance experience in a regulated manufacturing environment, preferably medical devices or other regulated industry.

Certifications (Preferred):

• CQE, CRE, CQA, Six Sigma Green or Black Belt

Skills & Competencies

• Strong knowledge of root cause analysis, DOE, statistics, lean manufacturing, risk management, and Six Sigma methodologies.
• Proficient in Microsoft Office and Minitab.
• Familiarity with metals processing and Toyota Production System is a plus.
• 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.

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life-enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.