Manufacturing & Quality Engineering Manager

Marmon Holdings, Inc.•Angola, IN

8d•Onsite

About The Position

Precision Edge Surgical Products Company LLC, a part of the global industrial organization Marmon Holdings (backed by Berkshire Hathaway), is seeking a Manufacturing & Quality Engineering Manager for its Angola, Indiana location. Precision Edge is a renowned contract manufacturer of fine surgical components, cutting tools, and accessories, committed to producing high-quality products that offer a competitive edge. The company values making a positive impact, providing diverse learning and working opportunities, and fostering an empowering culture.

Requirements

Bachelor’s degree in Engineering, Business Management, Business Administration, or related field.
10-15 years directing, managing or supervising engineering and quality functions or willing to work with a dynamic individual with fewer years’ experience.
Experience implementing New Product Releases to manufacturing required.
Strong background in manufacturing processes, new product release, and estimating.
Proven ability to direct and manage resources.
Ability to lift 50 pounds.
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.

Nice To Haves

Advanced degree highly desirable.

Responsibilities

Leads and directs all product development, change orders, and production support through the Process Engineers, Programmers, and Tooling Managers.
Manages personnel to obtain maximum efficiency and meet performance objectives.
Controls significant manufacturing projects and has responsibility for continuous improvement and cost reductions.
Provides strong leadership, sets high standards, and provides coaching to direct reports.
Promotes a team-based environment, positive atmosphere, open door policies, and a harassment-free work environment.
Manages engineering personnel directly or indirectly.
Ensures that personnel are trained for their job positions.
Delegates to appropriate personnel, ensuring decisions are made at the appropriate level.
Assists annually with the budget process and Strategic Planning.
Supports Monthly Management Report (MMR) analysis and generation.
Actively supports and enforces safety and environmental standards.
Ensures product quality meets or exceeds customer requirements.
Responsible for the measuring and monitoring of the Quality Management System and implementing continuous improvement activities to correct deficiencies.
Responsible for developing, implementing, and maintaining a shop floor inspection system that provides operators with the necessary tools to successfully perform their inspection activities and meet customer expectations.
Works directly with customers to identify and correct product quality issues and corrective actions.
Authorized to withhold any shipment deemed unacceptable/nonconforming.
Initiates cost reduction and quality improvement programs.
Maintains awareness in technical advancements and develops new processes based on them.
Monitors and initiates corrective actions with respect to scrap and rework.
Oversees the Corrective Action and Preventive Action (CAPA) process or designates a member of Quality to ensure the CAPA procedure is followed and the CAPA system is effective.
Performs statistical analysis of processes, tools, gages, and products, aimed at exceeding customer requirements and continually improving internal quality standards.
Identifies relevant quality-related training needs and delivers training as needed.
Responsible for all Quality communications.
Trains employees as needed.
Leads and attends routine meetings to resolve issues and drive improvement.
Directs and implements continuous improvement programs to reduce waste and improve productivity.
Supports all Functions as needed.
Ensures compliance with ISO Quality System requirements and FDA regulations.
Aids in the Management Review process per PE’s Management Review Procedure.
Supports Material Review Board (MRB) as needed.
Authority to sign for Director of Engineering and Quality for all engineering and quality related approvals.
Supervises Process Engineers, Engineering Interns, Quality Engineers, and others as defined.