Quality Engineer

Quality Engineer/Supervisor

Webster Groves,Missouri

Fulltime/Onsite

Position Summary

This position is responsible for the overall quality of manufactured medical products. In addition, this role leads initiatives for improved quality and cost savings for existing products. This role offers the opportunity to work closely with customers, sales, manufacturing, purchasing, and quality departments.

Essential Job Duties

• Quality Systems Management: Reviews, maintains, and updates the Quality Assurance Manual and other Quality department procedures.
• Audit Leadership: Prepares, plans, and leads all external regulatory and customer audits (ISO 13485 QMS) related to products manufactured onsite.
• Continuous Improvement: Leads, plans, and implements corrective actions and internal audits to ensure the highest product quality.
• Team Supervision: Supervises and directs the actions of Quality Inspectors and Quality Engineers. Coaches, counsels, and disciplines employees when necessary.
• Training: Trains employees on established work procedures and organizational processes.
• Engineering Collaboration: Works in collaboration with design and manufacturing engineering to implement new products and design changes, ensuring all products and processes meet customer and regulatory specifications.
• Cross-Functional Alignment: Works across all departments to ensure the organization is aligned with quality policies and meets all regulatory and customer requirements.
• Supplier Quality: Works with suppliers to drive corrective actions, maintaining a high level of quality. Leads the team in managing FAIRs and associated documentation.
• Complaint Resolution: Leads and drives all customer complaints and corrective actions to resolution. Maintains and updates customer complaint documentation.
• Technical Ownership: Serves as the technical lead on incoming and in-process inspection equipment selection and calibration requirements.
• Strategic Partnership: Works alongside senior quality and operations leadership to drive total product quality and a spirit of continuous improvement.

Qualifications And Requirements

Required Education

• Bachelor's degree or equivalent experience, along with 2 to 5 years of successful supervisory and quality experience in a manufacturing environment.

Required Experience & Skills

• Experience in the medical device field or a regulated environment (EU MDR, FDA GMP, and MDSAP preferred).
• Experience in high-pressure flow control valves is a plus.
• Knowledge of machining and other manufacturing processes.
• Knowledge of Lean Manufacturing, Design for Manufacturing, ISO Quality Systems, 8D Corrective Actions, and the PPAP process.
• Strong problem-solving, decision-making, and organizational skills with sharp attention to detail.
• Team player with a strategic focus and the ability to manage competing priorities for timely project completion.
• Strong oral and written communication skills.
• Proficient with Microsoft Excel, Word, and PowerPoint.
• Ability to support efforts for continuous process efficiency and cost reduction.

Desired Experience & Skills

• Self-starter, energizing, results-oriented, and able to multi-task.
• Excellent cross-functional teamwork, coordination, and communication skills.
• Ability to meet aggressive reliability, performance, cost, serviceability, and delivery targets.
• High commitment level to delivering results.

Work Environment

Work is performed in an office environment with regular interaction on the manufacturing floor and within the Engineering Test Lab.