Manufacturing & Quality Engineering Manager

Precision Edge Surgical Products Company LLC

As a part of the global industrial organization Marmon Holdings—which is backed by Berkshire Hathaway—you’ll be doing things that matter, leading at every level, and winning a better way. We’re committed to making a positive impact on the world, providing you with diverse learning and working opportunities, and fostering a culture where everyone’s empowered to be their best.

Welcome to Precision Edge Surgical Products!

Precision Edge is a world-renowned contract manufacturer of fine surgical components, cutting tools and accessories. As a surgical cutting tool manufacturer, we pride ourselves in our technical versatility and ability to assist our customers. We understand the fundamental requirement of superior performance from a surgical instrument and our team takes extreme pride in building quality products which provide a competitive edge for our customers.

We are currently hiring for a Manufacturing & Quality Engineering Manager in our Angola, Indiana location. If you meet the requirements below, we welcome you to apply.

DEPARTMENT: Engineering

JOB TITLE: Manufacturing & Quality Engineering Manager

FLSA STATUS: Salary Exempt

• 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

A successful Manufacturing & Quality Engineering Manager will have knowledge in or be able to achieve the Job Qualifications below.

Reports To

• Director of Engineering and Quality

Education/Experience

• Bachelor’s degree in Engineering, Business Management, Business Administration, or related field; advanced degree highly desirable
• 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

Essential Functions, Knowledge and Competencies

• 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

Responsibility/Authority

• Leads and directs all product development, change orders, and production support through the Process Engineers, Programmers, and Tooling
• 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 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 our customers to identify and correct product quality issues and corrective actions. Authorized to withhold any shipment deemed unacceptable/nonconforming
• Provide strong leadership, set high standards and provide coaching to direct reports
• Promotes team-based environment, positive atmosphere, open door policies and a harassment-free work environment
• Delegates direct reports and others, ensuring decisions are made at the appropriate levels
• 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
• Oversee the Corrective Action and Preventive Action (CAPA) process or designate 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 our internal quality standards
• Identifies relevant quality-related training needs and delivers training as needed
• Responsible for all Quality communications
• Train employees as needed
• Leads and attends routine meetings to resolve issues and drive improvement
• Direct 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
• As needed, supports Material Review Board (MRB)
• Authority to sign for Director of Engineering and Quality for all engineering and quality related approvals

Supervisory Responsibilities

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

Following receipt of a conditional offer of employment, candidates will be required to complete additional job-related screening processes as permitted or required by applicable law.

We are an equal opportunity employer, and all applicants will be considered for employment without attention to their membership in any protected class. If you require any reasonable accommodation to complete your application or any part of the recruiting process, please email your request to [email protected], and please be sure to include the title and the location of the position for which you are applying.