Jr Quality Assurance Manager (f/m) Life-changers work here CareFusion Life-changers find innovative ways to improve our customers ability to provide healthcare to their patients. One way is our search for bold and inspired employees across the globe. Are you ready to change lives? Join our 15,000 employees to help clinicians solve some of healthcares most critical challenges. Meet one of our Life-changers. youtube/carefusion About this company CareFusion is a global corporation serving the health care industry with products and services that help improve the cost and safety of health care for generations to come. The company develops market-leading technologies including Alaris® infusion pumps, Pyxis® automated dispensing and patient identification systems, AVEA®, AirLife™ and LTV® series ventilation and respiratory products, ChloraPrep® skin preparation products, MedMined™ services for data mining surveillance, V. Mueller® surgical instruments and an extensive line of products that support interventional medicine. CareFusion employs more than 15,000 people across its global operations. Job Title: Jr Quality Assurance Manager About this company Accountabilities The job holder’s duties or responsibilities are not limited to those listed below. The job holder is expected to perform other duties and responsibilities as assigned by the Senior Manager Quality. This position provides leadership to the CFN BH plant in Una Sana Canton the implementation and maintenance of the Quality Management System with particular regard to the manufacturing of infusion disposables in compliance with the CareFusion Quality Policy, the Medical Device Directive 93/42/EC (and its amendments), ISO 13485 and other relevant GMP standards or (country specific) regulations; This position develops, manages and achieves quality, budget and resource objectives; This position acts as the Management Representative; Principle duties and responsibilities The job holder’s duties and responsibilities include any of the following: Leads site management reviews, and represents CFN BH in risk assement meetings, toll manufacturer and infusion business line quality management reviews; Leads surveillance and certification audits conducted by regulatory bodies and corporate auditors Leads the quality organization to: Ensure key (quality) performance indicators are collected, analyzed (using statistically valid methods) and reported to key stakeholders (internal and external to the CFN BH plant), areas for improvement are identified (product design, manufacturing process, equipment and/or the QMS), initiates and lead continuous improvement projects by applying relevant methods; Ensure (sustaining) engineering projects (as pertaining to the CFN BH plant) are supported by providing quality engineering input pertaining to Design Transfer to Production (DTP), Design Verification and Validation (V&V), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) activities; Ensure the development and implementation of sampling plans, statistical analysis, measurement, test and inspection procedures; Ensure supplier-related issues are identified and resolved, ensures timely resolution of supplier failure, corrective actions and preventive actions, establishes and implements supplier’s outgoing inspection program, communicates with suppliers in matters related to component quality deficiencies; Ensure Leads and/or supports process and/or product related risk assessments, failure investigations, establishes detailed failure investigation reports to faciliate timely implementation and/or closure of NCMRs, CAPAs and Customer Complaints; Ensures Process Control Plans are written and kept current and effective, using appropriate statistical tools QUALIFICATIONS These are only prefered qualifications for this position at this grade level. Other factors are taken into consideration when deciding what position and grade level to place an employee such as performance level, capable contribution level and company need. technical degree plus proven quality engineering experience within the medical technology industry or equivalent, or equivalent combination of education and experience; Team management experience Sound knowledge of ISO 13485 and Medical Device Directive 93/42/EEC requirements; Good written and oral communication in English; Good prioritizing, organization, interpersonal, communication and analytical skills; Work independently with minimum supervision, across multiple geographics and functions; Sound knowledge of statistical techniques (Gage R&R, Acceptance Sampling, Process Capability, Statistical Process Control, Anova); Sound knowledge of process validation techniques; Sound knowledge of failure investigation techniques (8M, Cause and Effect Analysis); Good computer skills (MS Office); Advanced knowledge of lean methods (5S, LSS, Kaizen); Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Lokacija:Cazin Broj pozicija:1 Datum objave:28.11.2014. Trajanje oglasa:15 dana (ističe 13.12.2014.)
Posted on: Mon, 01 Dec 2014 14:15:16 +0000
Trending Topics
Recently Viewed Topics
© 2015