| Flex-Cell Precision, Inc., a high-end, Pennsylvania Machine Shop, seeks an experienced, motivated and energetic Quality Assurance Manager. The position is responsible for the overall quality program, and maintenance and application of our existing ISO 9001:2015 & ISO 13485:2016 quality management systems (QMS). The position oversees the Quality Lab as well as leading and supervising a small group of Quality Engineers & Technicians. Objectives: Maintain QMS compliance to current standards ( ISO 9001:2015/ISO 13485:2016 ). Foster continuous improvement Company wide. Champion positive trends in KPI’s by promoting a quality-centric culture. Introduce and maintain quality principals and tools ( SPC/Lean/Six Sigma etc. ) to complement existing processes. Basic responsibilities include: • Administering and enhancing the Quality Management System (QMS) • QMS Representative (Management Rep.) • Staying abreast of ISO, industry, regulatory and customer standards/requirements and ascertain any impact any changes may have on the Quality Management System. Making the necessary adjustments to maintain compliance including upgrading to the most current ISO standard. • Lead Internal Auditor responsibilities. • Prepares and Leads Customer, Vendor, Internal and External (Registrar) Audits. • Corrective/Preventative Action and Non-Conformance responsibility. • Training site personnel to ensure an understanding and adherence to QMS. • Prepare and conduct Material Review Board (MRB) meetings as required. • Participate in internal meetings as required. • Develop new quality policies and Standard Operating Procedures as needed • Support continuous improvement initiatives in conjunction with Management by coordinating the collection and analysis of quality metrics and audit results. • Manage calibration of measurement and test equipment. • Visits Customers and Vendors regarding quality related issues/audits as required. • Review Customer specifications as needed. • Administer process validation activity. • Continually assess risk as it pertains to ISO standards (QMS) • Conducts annual performance reviews of Quality Team members. | 
