Manufacturing Quality Engineer 2

About the role

Supporting and improving product and process quality across manufacturing operations
Leading and supporting nonconformance investigations and CAPA activities, including root cause analysis and implementation of corrective actions
Partnering with manufacturing and operations teams to strengthen process robustness and reduce variation and defects
Applying risk-based thinking using tools such as PFMEA to identify and mitigate process risks
Developing and optimizing inspection strategies, including measurement system analysis
Performing data analysis using statistical tools such as control charts and capability analysis
Supporting process validation activities including IQ, OQ, and PQ

Responsibilities

• Supporting and improving product and process quality across manufacturing operations
• Leading and supporting nonconformance investigations and CAPA activities, including root cause analysis and implementation of corrective actions
• Partnering with manufacturing and operations teams to strengthen process robustness and reduce variation and defects
• Applying risk-based thinking using tools such as PFMEA to identify and mitigate process risks
• Developing and optimizing inspection strategies, including measurement system analysis
• Performing data analysis using statistical tools such as control charts and capability analysis
• Supporting process validation activities including IQ, OQ, and PQ

Requirements

• Education: Bachelor’s degree in Engineering such as Mechanical, Biomedical, Industrial, or a related discipline
• Experience: 1 to 3 years of experience in quality engineering within a manufacturing environment
• Experience working in a regulated industry
• Knowledge: Strong understanding of quality standards and regulations including ISO 13485 and FDA 21 CFR Part 820
• Ability to apply statistical analysis and quality engineering principles to solve problems and drive improvements

Qualifications

• Strong understanding of quality standards and regulations including ISO 13485 and FDA 21 CFR Part 820
• Ability to apply statistical analysis and quality engineering principles to solve problems and drive improvements

Skills

• Quality Engineering
• Statistical Analysis
• Risk-Based Thinking
• Process Robustness Improvement
• Measurement System Analysis
• Data Analysis
• Process Validation

Benefits

• Competitive bonus and benefits package
• Medical, dental, and vision coverage
• 401k
• Tuition reimbursement
• Medical leave programs
• A variety of wellness offerings

Pay

The anticipated base compensation range for this position is $74,250 - $111,500 USD annually.

Schedule

Hybrid Work Model (For most professional roles)