(LOWELL, MA)--After several months of intense review and assessment of its specialized on-boarding program by an independent, global agency, Operon Resource Management, headquartered in Lowell, Massachusetts, announced that the company has been awarded ISO 13485 certification. This new certification, a rarity for staffing firms, provides medical device and healthcare product manufacturers a level of trust that Operon's trained workforce is uniquely qualified for the highly regulated environment the Device Industry often requires.
The certification, officially titled ISO 13485 Quality Management Systems Standard for Medical Devices Manufacturers and Related Services, was awarded by BSI, Inc., the leading global independent business conformity assessment organization. Operon is the only known staffing firm in the country to attain this certification. This standard of certification for management systems is typically attained by the healthcare product manufacturers themselves.
Operon has developed a customized on-boarding program, called The Operon Gate™, that includes rigorous screening and ISO-compliant job training for entry-level workers. This training program puts inexperienced job candidates through an extensive course of training and gives them the necessary background to succeed on the manufacturing floor. Operon provides skills and knowledge to these workers that can be used to gain permanent and good-paying employment for life.
"Our cutting-edge and customized job training process produces qualified and capable workers to fill the specialized needs of our clients," said Steve Sawin, the President and CEO of Operon. "Our goal is to help our clients succeed and thrive; this certification is a way of ensuring the highest quality of our job training and total on-boarding services."
These highly trained workers are now helping several medical device and healthcare product firms cope with surges in demand for their products. Among other skills, the specialized training modules developed by Operon teach workers how to function in the "clean room" environments required to manufacture many medical devices such as those used in: endovascular, graft, cardio thoracic, wound/reconstruction, blood/fluid flow, diagnostics, drug delivery, disposables, and other products.
"The availability of a trained workforce is a key factor in how medical device and broader life sciences companies will grow into the future," said Sawin. "This new level of assurance in Operon's procedures will help that growth," he said.
During 2013, Operon trained and employed over 1,200 workers in healthcare product manufacturing companies in New England alone.
"With this certification, there are a whole host of questions I don't have to ask about Operon's business and how they mitigate our compliance risk as a customer. In short, it increases trust," said John Taupier, Director of Operations at NP Medical, Inc. in Clinton, MA.
"Although we have been partnered with Operon for nearly a decade, this is another indication that they and their process, The Operon Gate™, are in lock-step with us as a leading medical device manufacturer and they are committed to our industry," said Jim Fitzgerald, Vice President of Operations at Atrium Medical Corporation in Hudson, NH.
Operon's expertise in the manufacturing and human resources fields is also being acknowledged on a national level. To help the industry address its workforce supply deficiencies, the Obama Administration and the U.S. Department of Labor created the Medical Device Harmonization Initiative, a grant-based project that provides funding for the Community College Consortium for Biosciences Credentials (c3bc). Operon was chosen to represent the Northeast in this consortium, the only staffing firm to play such a role. Two main objectives of this initiative are to create a set of medical device industry skill and knowledge standards and develop curriculum for a national network of community colleges that will elevate the skills and knowledge base of entry-level workers.
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Operon is the leading specialized provider of job training and workforce solutions for healthcare product manufacturers, including medical device and pharmaceutical companies. Operon's primary goal is to help manage manufacturers' labor needs more cost-efficiently without sacrificing quality, compliance or production. Operon has the resources and processes to address manufacturing, quality control and logistics needs, or other production labor, to meet a company's exacting requirements and highest standards. Operon is headquartered in Lowell, MA and services healthcare product manufacturers nationwide.
