Overview
ISO Compliance Engineer for modern CNC Machine Shop. This position will join the existing compliance team to maintain and continuously improve our quality system which is dual-certified to ISO 9001 and ISO13485. In this role, you will with work with all departments have responsibilities in multiple areas, including production, inspection, vendor management and customer support.
Relaxed, team-based work environment. Excellent long term employment prospects. All work on-site. Flexible hours for good work/life balance. Great benefits including excellent health plan with deductible paid 100% by the company and doctor visit co-pay reimbursement as well as dental, profit sharing / 401k plan, gym membership reimbursement and other benefits. We pride ourselves on creating an excellent and respectful work environment and the best evidence of that is that almost half of our employees have been with us for over 15 years.
Responsibilities
Help find resolution to customer complaints and quality issues via our Discrepant Material Report (DMR) and Corrective Action / Preventative Action (CAPA) systems.
Act as a liaison to our customers' Quality Engineers and provide support as required.
Interface with customers to develop appropriate inspection and quality plans
Contribute toward modification and improvement of quality system documents
Manage record-keeping process for document control
Manage record-keeping process for training
Plan and execute production capability studies as required.
Plan and execute equipment qualifications as required.
Follow up with vendors regarding documentation, reporting, and compliance issues.
Occasionally assist in the inspection of product as required to keep the flow of parts going.
Requirements
Bachelor’s degree in Engineering or similar field or equivalent work experience.
0-10 years of manufacturing engineering experience. Machine Shop experience a major plus
Practical knowledge of basic statistics. Familiarity with Minitab or similar analysis package is a plus
Experience with CMM or vision-based inspection system a major plus.
Experience with SolidWorks a major plus.
Experience in an ISO 9000 / ISO 13485 manufacturing environment a major plus.
Ability to read and understand mechanical technical drawings, including Geometric Dimensioning and Tolerancing (GD&T)
Experience communicating professionally with internal and external parties.
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.
Good with computers. Learns new things easily. Not afraid of challenges.
Strong skills in Microsoft Office (Word and Excel).
Solid 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.
Familiarity with ISO 9000 and ISO 13485 requirements
Compensation includes wages plus excellent benefits including a bonus program, well-funded health plan, dental, profit-sharing plan, and more. Modern company, clean shop, Air-conditioned work area.
High Tech Turning currently has 38 employees and was founded in 1985. We are an ISO 9001 / ISO 13485 certified precision manufacturer of Medical, Electronic, and Instrument components. We offer a modernized facility with newer equipment. For nearly 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 out over 8,000,000 custom CNC-machined parts in 2024. Many of our tolerances are as tight as +/-.0001” and many of the parts we make are smaller than a grain of rice.
