Interplex Medical Work Values

Daily Duties at Interplex Medical:

*Serve as Management Representative as required by ISO 13485 and FDA, 21 CFR 820 *Primary interface with regulatory agency personnel in regards to FDA factory inspections and ISO assessment audits *Provide technical guidance to all employees on the Regulatory cGMPs and ISO Standard. *Responsible for Quality Management System planning *Establish and maintain standard operating procedures to ensure compliance with regulatory and international standards *Conduct Management Reviews of the Quality Management System *Facilitate and prepare facility for inspections conducted by various outside agencies *Consult with senior management on production, deviations and regulatory decisions *Establish and maintain a quality monitoring system for product performance *Responsible for overall administration of the internal quality audit program which includes: Developing yearly internal audit schedule, selecting and training candidates on internal auditing *Monitoring and reporting status to senior management *Responsible for incident reporting, adverse event and recalls *Oversight of FDA submittals: Establishment Registration, Device Classification, Listings, and 510(k) *Direct Responsibility of the Quality Assurance/Quality Control *Department: First Article Inspections, Receiving Acceptance Activities, In-Process Inspections, and Final Acceptance Activities *Work with engineers to ensure new product and engineering changes are in compliance with Quality Systems Regulation and proper documentation of the Design History Files *Review and approval of all Design Control Verification Testing, Qualification/Validation Studies and Quality Control Plans *Responsible for staffing and managing the Quality Assurance /Quality Control Department *Evaluate and recommend organizational training programs *Provide Medical Device Quality Management System guidance & support to other Interplex Medical Device Divisions in New Jersey and California *Implemented the following Quality Management Systems: Documentation Control, Supplier Control System Product Release, Internal and Supplier Auditing Calibration System, Preventive Maintenance Complaint System, CAPA System MRB System (Material Review Board), Process Deviation System Design Controls

What they like about Interplex 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 Interplex Medical: