Quality Engineer

Responsibilities

• Lead projects to continuously improve the quality of products and processes.
• Act as a project leader and internal consultant, working closely with department managers and team leaders to define improvement targets, measure and analyze process capabilities, perform root-cause analysis, implement improvements, and control ongoing performance.
• Manage the quality system, customer concern processing, and support development/production processes.
• Create and maintain design and process risk analysis (e.g., FMEAs).
• Work with Operations, Engineering, Supply Chain, and Sales on risk mitigation activities.
• Identify and report quality-related trends and develop processes/systems to detect those trends proactively and respond accordingly to improve product and process quality.
• Lead the implementation of standard quality systems/processes for the detection, control, and remediation of production quality issues.
• Initiate capital investment requests or other strategic activities to improve product and process quality.
• Coordinate and lead cross-functional efforts to address quality concerns or drive improvement in current performance.
• Work directly with customers on quality concerns, including response to issues and conflict resolution.
• Teach and coach best practices in problem-solving, root cause analysis, statistical quality control, and authoring work instructions.
• Participate in the internal audit system and provide assistance to teams in resolving corrective actions.
• Support quality improvement projects as deemed necessary by the organization.

Requirements

• Bachelor's degree (B.S.) from a four-year college or university in Engineering, Statistics, or a related field; or four years of related experience and/or training; or equivalent combination of education and experience.
• Shop floor experience in troubleshooting and resolving daily quality issues.
• Strong analytical skills, including the use of simple and complex quality tools.
• Working knowledge to perform and lead kaizens.
• Solid verbal and written communication skills.

Preferred Qualifications

• Deep software skills, including MS Office, ERP, and statistical analysis tools like Statistica or Minitab.
• Background in Total Quality Management (TQM), FDA Good Manufacturing Practices (GMP), and ISO 9000 concepts.
• Certification or specialized training in Statistical Process Control (SPC) and Design of Experiments (DOE).
• 6+ years of experience as a Senior Quality Engineer.
• Visual detection, PLC automation/controls experience, and knowledge.
• Experience developing and implementing quality systems/processes within existing business units.

Working Conditions

• Prolonged periods of sitting at a desk and working on a computer.
• Manufacturing environment.
• Must be able to lift up to 50 lbs.
• Various levels of gowning are required.

Special Requirements

• Ability to travel (US and internationally).
• Ability to work evenings and/or weekends.