Manufacturing and Quality Engineering Manager

Precision Edge Surgical Products Company LLC, part of the global industrial organization Marmon Holdings—backed by Berkshire Hathaway—offers opportunities to lead at every level, drive meaningful impact, and grow within a culture that empowers everyone to excel.

About the role

This position manages daily technical support for product lines, leads design, development, and modification of products, and oversees expansion and modernization of manufacturing facilities.

Responsibilities

• Lead and direct all product development, change orders, and production support through Process Engineers, Programmers, and Tooling.
• Manage personnel to maximize efficiency and meet performance objectives.
• Control significant manufacturing projects, focusing on continuous improvement and cost reductions.
• Provide strong leadership, set high standards, and coach direct reports.
• Promote a team-based environment with open-door policies and a harassment-free workplace.
• Manage engineering personnel directly or indirectly, ensuring proper training for job positions.
• Delegate tasks appropriately to ensure decisions are made at the correct level.
• Assist annually with the budget process and Strategic Planning.
• Support Monthly Management Report (MMR) analysis and generation.
• Actively enforce safety and environmental standards.
• Ensure product quality meets or exceeds customer requirements.
• Measure and monitor the Quality Management System, implementing continuous improvement activities to correct deficiencies.
• Develop, implement, and maintain a shop floor inspection system to equip operators with tools for successful inspections.
• Work directly with customers to identify and correct product quality issues and corrective actions.
• Authorize withholding of any shipment deemed unacceptable or nonconforming.
• Initiate cost reduction and quality improvement programs.
• Maintain awareness of technical advancements and develop new processes based on them.
• Monitor and initiate corrective actions for scrap and rework.
• Oversee the Corrective Action and Preventive Action (CAPA) process or designate a Quality team member to ensure its effectiveness.
• Perform statistical analysis of processes, tools, gages, and products to exceed customer requirements and improve internal quality standards.
• Identify and deliver quality-related training as needed.
• Train employees and lead routine meetings to resolve issues and drive improvement.
• Direct and implement continuous improvement programs to reduce waste and improve productivity.
• Support all functions as needed, ensuring compliance with ISO Quality System requirements and FDA regulations.
• Aid in the Management Review process per company procedures.
• Support the Material Review Board (MRB) as needed.
• Sign engineering and quality-related approvals on behalf of the Director of Engineering and Quality.

Requirements

• Bachelor’s degree in Engineering, Business Management, Business Administration, or a related field; advanced degree highly desirable.
• 10-15 years directing, managing, or supervising engineering and quality functions (willing to consider dynamic individuals with fewer years of experience).
• Experience implementing New Product Releases to manufacturing.
• Strong background in manufacturing processes, new product release, and estimating.
• Proven ability to direct and manage resources.
• Ability to lift 50 pounds.
• Comfortable with prolonged periods of sitting at a desk and working on a computer.
• Strong supervisory and team-building skills.
• Ability to drive change and effectively manage projects.
• Excellent working knowledge of manufacturing processes and new product release.
• Knowledge of ISO 13485 and 21 CFR 820.

Benefits

• Benefits starting on Day 1.
• Competitive pay.
• Knowledge-based promotions.
• Company-paid Short- and Long-Term Disability.
• Company-paid Life and AD&D Insurance.
• PTO and Company Paid Holidays.
• 401K with Company Match.
• Climate-controlled, clean work environment.

Supervisory Responsibilities

• Process Engineers
• Engineering Interns
• Quality Engineers
• Others as defined