Oversees all Quality and Regulatory Management activities as required by Rhein Precision’s QMS, ISO 13485, 21CFR820 and any other applicable regulation and/or requirements.
Chair the ISO Intiative with an objective of becoming certified to ISO 13485 in 2014. Maintain ISO certification by acting as ISO Management Rep and chairing the Management Review, CAPA and MRB programs.
Manage and participate in the development and control of all QMS related policies, procedures, work instructions and forms of internal and external origins.
Manage and lead the QA Inspection department by performing training, staffing and working with the Lead QA Inspector to assure compliance and deadlines are met.
Represent the Quality Department during all customer and third party audits and communications relative to quality concerns and inquiries.
Responsible for conducting routine Internal Audits, Supplier Audits and alike.
Position requirements & experience:
Minimum of 5 Years in a senior Quality Management Position in a manufacturing environment.
Proficient in effective communication skills within and outside of an organization. Computer literacy a must.
Proficient in all aspects of a Quality Function including auditing, CAPA, MRB, pFMEA’s, Risk Assessment, Management Review, First Articles, Calibration, etc.
From its inception as a traditional instrument making company in 1991, Rhein Precision has developed its high tech machining environment with the same quality attitude. Routinely working in tolerances below .0005”, Rhein Precision has blended the two environments to give our customers a very unique service.
Rhein Precision supports projects from prototype development to volume production with e...qual ease. We have the manufacturing and design expertise to assist our customers at all levels of product manufacturing. Through our sister company, Rhein Medical, located in St. Petersburg Florida, we offer Engineering Support, Clean Room Assembly, Sterile Packaging and Sterilization Management.