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Within 2019, Precision Coating’s quality management system for anodic coating services for medical devices was audited and found to be fully in compliance with the ISO 13485:2016 standard. The company was certified by the Notified Body, SGS United Kingdom Limited for the application of anodic coatings, including MICRALOX® Ultra and Lumina. The company’s fluoropolymer coating subsidiary is also ISO-13485:2016 accredited by SGS.
The company was awarded a Massachusetts-backed Workforce Training Fund Program grant to enhance productivity and business growth. The award will support training of current employees in three areas:
- Lean and Continuous Improvement – focus on improvements to processes and systems that will impact quality, cost, lead-time and flexibility, and make the best use of current resources (people, equipment, material and space).
- Workplace Communication – focus on English for speakers of other languages, to support the ability to follow verbal and written job instructions.
- FDA/Quality Systems and Good Manufacturing Regulation Training – focus on teaching employees the need for, requirements of and benefits from compliance with quality and manufacturing system guidelines for customer specification and medical device regulations.
To further support growth this year, PCCI promoted Mike Sung, Ph.D., to Vice President of Engineering and Technology, Anodic Coatings. Sung is the author and presenter of over 30 technical papers and holds 10 patents, including Precision Coating’s proprietary MICRALOX anodic coating. He is responsible for developing, engineering and scaling critical equipment, chemistry and manufacturing processes for MICRALOX products, and leads the coordination of technical activities externally with customers, and internally with cross-functional teams.
The company also promoted Chynna Lopes to the newly-created position of Technical Sales Manager, Anodic Coatings. Previously, she served as Quality Manager, where she led the organization through ISO 13485 certification.
The creation of this position stands as another indication of Precision Coating’s continued growth, which over the last few years has included a substantial competitor acquisition, a new PTFE coating facility in Costa Rica, and further advancements of its family of proprietary MICRALOX technologies.
