Relieance Medical Work Values

Daily Duties at Relieance Medical:

 Responsible for a wide variety of quality assurance activities, primarily in support of FDA Quality System Requirements, International Standards ISO 13485 & ISO 9001:2000, EU Medical Device Directive 93/42/EEC and CMDR.  Established and maintained Reliance SOP (standard operating procedure) to ensure compliance with applicable regulation and requirements.  Responsibilities include translating regulation, requirements, and corporate guidelines into company and Business Sector policy.  Primary company interface with regulatory agency personnel, including oversight of FDA factory inspections, UL&CSA field inspection and ISO assessment audits.  Responsible for overall administration of the internal quality audit program, which includes develops and distributes an annual internal auditing schedule, selecting and training internal auditors, monitoring and reporting status of open audits.  Facilitate and prepares facility for inspections conducted by various outside agencies.  Prepare Audit Reports and verify the implementation and effectiveness of the corrective actions.  Responsible for Incident Reporting/Adverse Event and Recalls.  Oversight of 510(k) submittals  Communicate quality trends to executive management by conducting Management Review to monitor and assess the Quality Management System.  US Agent for Haag-Streit AG for FDA issues.  Oversight of the internal CAPA (corrective action & preventive action) System  Responsible for Establishment Registration & Device Listing of product to FDA.  Direct Responsibility of the Quality Control/Quality Assurance Department; 1st Article Inspection Acceptance Activities, Receiving Acceptance Activities, In-Process Acceptance Activities, & Electrical Subassembly Acceptance Activities  Oversight of Calibration Lab & Nonconformance Material Area  Work with Engineering and Manufacturing Engineering to ensure new product and engineering changes are in compliance to Quality Systems Regulation (QSR) and proper documentation of the Design History File (DHF).  Develop and Maintain Quality Assurance Department Budget  Responsible for staffing and managing the Quality Assurance/Quality Control Department Manufacturing Engineer 1998 - 2001 Responsibilities:  Worked closely with research and design engineering to transfer new products into manufacturing  Participated in design review, identifying critical points for design transfer.  Lead pilot production into manufacturing  Worked with Manufacturing Management to oversee the development of the Manufacturing Processes  Interfaced with Quality Assurance to assure that the manufacturing processes meet regulatory requirements.  Supported manufacturing on trouble shooting electronic/electrical product problems  Designed test fixtures to test electrical subassemblies  Designed test fixtures for our subcontract manufacturers to test printed circuit boards  Provided support to Customer Service on customer complaints and corrective action requests.  Conducted post production run review  Validation of Equipment and manufacturing processes Manufacturing Supervisor 1995-1998 Responsibilities:  Managing staff, preparing work schedules and assigning specific duties.  Forecast, plan, and direct resources to achieve department and company objectives and participate in long-range business planning and budget preparation  Maintained accurate records documentation related to training  Provided guidance and on the job training to employees to improve techniques and skills  Determine staffing requirements, and interview, hire and train new employees  Assured Good Manufacturing Practices and Safety guidelines were followed  Worked with Assemblers and Manufacturing Engineering to continuously improving processes.  Overseen movement of material into the workstation, as well as movement of product output.  Maintained productivity matrices as assigned.  Assisted R&D and Manufacturing Engineer, with product transfer activities  Review business plan and adjust labor force to meet goals of the division’s plan  Primary technical troubleshooting resource for solving complex manufacturing issues.  Coordinate part inspection techniques with Engineering and Inspection to allow correlation upon part completion Delta Coventry, Cincinnati, Ohio Component Engineer/Manufacturing Coordinator 1991-1995 Research & Development of Electronic Ballast for HID Lighting Responsibilities:  Worked with design engineers and suppliers to select electronic components to meet electrical specification and manufacturability.  Qualifying all active and passive electronic components and suppliers.  Costing, sourcing, and purchasing of all electronic components and customize components.  Sourcing and negotiating with subcontract manufacturers such as: assembly of electronic printed circuit boards manufacturers, coil/transformer winding manufacturers and electronic circuit board layout designers.  Responsible for the control of all engineering changes and manufacturing documentation  Bread boarding, prototyping, and testing of Electronic Ballast Design  Coordinator between engineering and printed circuit board designer  Coordinator for US Safety Testing  Responsible for all of subcontractor manufacturing activities

What they like about Relieance Medical:

Working in an organization that is technologically advanced, creative, and innovative is critical in your assessment of hiring companies. Less important to you are stability of the organization, the length of time an organization has been in business, and the business' plans for the future. You prefer a fast-moving company that will take risks to achieve its goals and objectives. The length of time the company has been in business is irrelevant. Maintaining status quo is unnecessary. You thrive on change, uncertainty and the upside of potential business risks, especially those associated with innovation. Stability for the long haul is not nearly as important as is working in an atmosphere that is charged with a sense of urgency and constant change.

Tags

Audit, Engineering, Management, Management Review, Manufacturing, Medical, Quality, Quality Assurance, Quality Control, Regulatory Affairs, steel, medical device, medical devices, Quality Director, Director of Quality & Regulatory

Skills

These are some of the questions we asked our climbers about their experiences with Relieance Medical: