Director-Medical Device Quality

Job Category: Quality Assurance/Safety Relevant Work Experience: 7+ to 10 Years Career Level: Manager (Manager/Supervisor of Staff) Education Level: Bachelor's Degree Reference Code: 14020 Director-Medical Device QualityLocation is flexible.  We provide very competitive comp/bonus/benefits. Flextronics is a leading Electronics Manufacturing Services (EMS) provider focused on delivering complete design, engineering and manufacturing services to automotive, computing, consumer digital, industrial, infrastructure, medical and mobile Original Equipment Manufacturers (OEM)s. Flextronics' Medical Segment provides world-class design, manufacturing, and logistics solutions to medical device and equipment companies. As a large, recognized leader in the EMS industry, Flextronics provides a broad set of capabilities for medical customers in the invitro-diagnostic, drug delivery, and lab equipment industries. The Director of Quality and Process Improvements is a new position with global responsibilities for quality process improvement internally and with suppliers, managing FDA inspections, and supporting medical manufacturing culture.  Location is flexible.  Key functions are:  Lead FlexMedical Process Robustness Initiative and collation of improvements across sites, as well as working close with suppliers to improve their processes to avoid components failure. Ensure FlexMedical sites are compliant to applicable regulatory requirements, FlexMedical policies etc. Train and help with Global SMT Validation, implementation, as well as other medical training as needed Support/ help in Supplier Assessments Support sites and Business development with customer visits and presentation Lead all sites FDA inspections Identify and Initiate and manage any necessary improvements at sites based on audit findings and/or customer complaints Create FlexMedical policies as required and/or needed Support ISO-13485 certification when required and auditing experience. Support program/business transfers as needed Help implement Reliability Program across FlexMedical global footprint Key requirements include an Electronic Medical Devise background, an Electrical or Electronics degree, and thorough knowledge of IEC 60601 standards. Industry Requirements:   Minimum 7-10 years in Medical Industry, preferably Medical Electronic Manufacturing, with wide range of FDA/EU/PAL experience. Must have lead and/or participated in 3-5 FDA and Notified Body Audits, and responded to or managed responses to 483. Working knowledge on Managing Recalls, MDR and Root Cause Analysis. Must be able to be hands-on in validating huge systems integration as well as SMT (Surface Mount Technology) validation according to the FDA and GAMP requirements. Must have thorough knowledge of IEC 60601 as well as other Medical Electronic Industry Standards. Working knowledge of software validations requirements. Must have requisite industry certifications i.e CQA, RAC CQE.     Educational Requirements:   A bachelor’s degree in a science field is required, preferably Electronic Engineering, and Masters degree, although not a requirement, would be an advantage.   Other Requirements   This position will require 40-60% travel. Individual should be a high performer who requires minimal supervision, a self directed starter, eloquent and persuasive, able to communicate difficult concept easily to team members, customers and regulators, able to manage large team meetings, be able to work effectively across cultural and geographic boundaries, able to manage customer meetings and regulatory audits, proficient writer of documents, policies and procedures, with an inherent drive to add value to everything he/she sees. Must collaborate with other segment leaders and site leaders to share and persuade them on medical requirements and use of medical developed systems. Please include a cover letter outlining your match to the requirements.  Click here to apply for this job http://flextronics.ats.hrsmart.com/cgi-bin/pm/click.cgi?job_id=14020&site_id=123