Overview Engineering and Compliance Manager for Modern CNC Machine Shop. This position will support and lead our engineering capabilities and efforts to maintain and continually improve our quality system, which is dual-certified to ISO 9001:2015 & ISO 13485:2016. This position reports directly to the president. High Tech Turning currently has 34 employees and was founded in 1985. We are a precision manufacturer of Medical, Electronic, and Instrument components. We offer a modernized facility with newer equipment. For 40 years, the company has taken components from pre-production prototyping through high volume production with quantities in the 100,000s and up. High Tech Turning has received the "Honors Program" award and has been rated as one of the “Top Shops in the US” by Modern Machine Shop Magazine. Our shop is very clean and we have a commitment to utilizing top-of-the-line equipment to achieve exacting quality standards. We produce high-volume, high-precision machined components mainly for medical devices. We shipped over 8,000,000 custom CNC-machined parts in 2024 and we are on track to ship close to 9,000,000 parts in 2025. Many of our tolerances are as tight as +/-.0001” Most of the parts we make are smaller than a grain of rice. Relaxed, team-based work environment. Flexible hours for good work/life balance. Great benefits including excellent health plan with deductible paid 100% by the company, doctor visit co-pay reimbursement, as well as dental, profit sharing / 401k plan, gym membership reimbursement, and other benefits. We pride ourselves on the fact that our company has a family feel where everyone is treated with respect. We work hard to create an excellent work environment and the best evidence of that is that over 50% of our employees have been with us for more than 10 years, with several over 30 years. High Tech Turning is a small company where everyone makes contributions to our success. The managers are “hands-on” and perform work, and don’t just manage others. The flow of work is ongoing and we all contribute to keeping the jobs and projects moving forward. In order to fit into our culture, you will need to be the type of manager who “leads from the trenches”, and doesn’t just expect the people who you manage to perform the tasks while you only do the planning. Responsibilities • Lead Engineering group activities, with support from Manufacturing and Quality Engineers: o Interface with customers to develop appropriate inspection and quality plans. o Analyze output to assure all parts are in compliance with customer requirements. o Continue rollout of SPC data collection/analytic software “High QA.” o Help roll out data techniques to the shop floor. Help write and update procedures. o Manage manufacturing and quality engineers, including hiring. • Lead Compliance Group activities with support from quality engineers and admins: o Maintain ISO 9001 / 13485 registration and continue developing the quality system. o Manage relationship with our outside registrar / accrediting body o Development and management of manufacturing & ISO documentation. o Create and edit procedures, work instructions, forms, flowcharts, etc. as needed. o Maintain our Document Control System / Revision Control System. o Maintain our training record database. o Manage our supplier quality database, perform vendor audits as required. o Oversee internal audits, maintain records, work to address any findings o Respond to customer complaints and solve quality issues that arise. o Manage our Corrective Action / Preventative Action (CAPA) system. o Maintain MSDS and safety information • Oversee mechanical inspection group, including Quality Manager and his inspectors. o Provide expert-level advice on GD&T. o Act as final arbiter for internal quality disputes o Aid the Material Review Board in determining root cause and disposition of non-conforming material. Requirements • Bachelor’s degree in Engineering or similar field or equivalent work experience. • 10+ years of experience in a manufacturing field. • 5+ years of employee management • Machine shop experience a major plus. • Excellent familiarity with CNC machining processing and “Good Manufacturing Practices”. • Ability to read and understand technical mechanical drawings, including Geometric Dimensioning and Tolerancing (GD&T). • 5+ years of experience directly working in ISO compliance. • Skill in interpreting and applying regulations and other guideline materials • Experience with the ISO implementation/certification process a major plus. • Practical knowledge of statistics. Familiarity with Minitab or similar analysis package is a plus. What you need to succeed • Team player with easy-going attitude. Works well both independently and with others. Working well and easily with the rest of the team is the most important factor for your success. • “Hands-on” leader that is comfortable both performing and delegating work. • Good with numbers and computers. Learns new things easily. Not afraid of challenges. • Strong skills in Microsoft Office (Word and Excel). • Excellent communication skills (verbal and written), Strong technical writer. Good email skills. • Attention to detail. You are the type of person who catches their own mistakes. • Strong familiarity with ISO 9000 and ISO 13485 requirements Compensation includes wages plus excellent benefits including a well-funded health plan, dental, profit-sharing plan, and more. Modern company, clean shop, Air-conditioned work area. Relaxed work atmosphere. Excellent long term employment prospects.