Lead RAQA Specialist, Poland in Warszawa at Stryker Corporation

Date Posted: 11/5/2018

Job Snapshot

Job Description

"Quality Assurance
  • Ensure that the Quality Management System is implemented and maintained in accordance with the requirements of the ISO 9001/13485 and the Stryker EU QA guidelines and procedures
  • Organize at fixed intervals, formal Management reviews of the Quality System to ensure and monitor its suitability, adequacy and effectiveness
  • Report on the performance of the Quality Management System, including needs for improvement
  • Ensure the control of the Quality Assurance documentation as needed
  • Plan and perform internal audits
  • Ensure awareness of customer requirements throughout the organisation to consistently provide products and services that meet customerers expectation
  • Address and evaluate customer satisfaction through the effective operation of the system, including continuous improvement
  • Local Quality procedure development and implementation according to the Divisional Policies
  • QA activities (Internal audit, external audit, SOP, CAPA and work instruction review)
  • When / If applicable, ensure that subcontracted distributors are regularly audited and perform in line with Stryker requirements
  Post Market Surveillance
  • Ensure that the Stryker EU post marketing vigilance SOP’s are properly delivered and implemented
  • In line with these procedures, liaise with the relevant authorities and with Customers when Complaints / product liability matters occur in Poland
  • Ensure that product legacy data (products traceability) are consistently and safely maintained
  • Monitor the closure of RA actions initiated for Poland and/or other regions and report progress as appropriate to local and European stakeholders
  Pre Market
  • Perform and/or coordinating contractors for registration/notification of products as per local regulatory procedures
  • Ensure that all local regulatory requirements are met before release of any product in the local market
  • Mointain records for all approved products and ensure a timely notification to business partners in case of product license expiry
  • Provide adequate and up-to-date documentation (ISO & CE Certificates, Declarations of Conformity and other customer-specific documents upon request ( tenders or speciol projects)
  • Ensure compliance with any new European/ local applicable regulation (packaging, battery, REACH, WEEE directives IEC, etc,)
  • Liaise with Distributors/ Local Competent Authorities /local Trode Associotions to ensure that any change in local/ requirements is identified timely and reported to the relevant stakeholders
  • Fluent in English & Polish (additional language desirable)
  • Degree graduate (Science/ engineering/business fields) or no less than 5 years experience working in QA/RA for a Medical Device or Pharmaceutical Organization
  • Qualification / certification in QMS auditing for ISO 13485 and/or ISO 9001
  • Proven Expertise in ISO 13485 Quality Management Systems and MDD vigilance
  • Proven Expertise in product registration or notification acivities
  • Well established communications with key stakeholders
  • At least 3 years of working experience in a a Medical Device or Pharmaceutical Organization
  • Proven and measurable track record on projects within RAQA environment (eg. CAPA/CARA, process improvements)
  • Work to strict deadlines and under pressure. 
  • Ability to execute plans / processes
  • Analytical & customer service skills
  • Administrative skills
  • Accurate and concientious
  • Creative but realistic
  • Ability to prioritise and organise own workload
  • Ability to analyse data and statistics
  • Embrace working with different geographical cultures
  • Customer orientated

Work From Home: No

Travel Percentage: None

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