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Quality Specialist

Company: SunMed
Location: Grand Rapids
Posted on: November 9, 2019

Job Description:

Position SummaryThe Quality Specialist is responsible for overall Quality Management System compliance with FDA Quality System Requirements, ISO 13485 standard and other applicable requirements. This position implements, maintains, and improves systems to ensure product meets defined quality requirements and customer satisfaction is met.
Position QualificationsThe specific minimum competencies needed to perform the essential duties of the job include knowledge, skills, abilities, level of education, and experience necessary for successful performance. These competencies are generally demonstrated through specific service, education, or training.
Knowledge: -- Knowledge of quality standards for medical devices (e.g. ISO 13485, FDA QSR, EU Medical Device Directives, and Canadian Medical Device Regulations).
Skills & Abilities: -- Excellent verbal and written communication skills. -- Excellent organizational skills and attention to detail. -- Ability to multi-task.-- Sound, systematic problem solving skills. -- Strong computer skills: MS Word, MS Excel (chart, pivot tables), PowerPoint, database management and statistical analysis
Level of Experience: -- A minimum of 4-6 years of Quality System experience in an FDA regulated and/or ISO certified facility (preferably ISO 13485).
Level of Education: Bachelor/Associates degree or equivalent work experience.
Travel: Amount of travel availability required for position.Occasional Overnight Travel Up to 10%
Essential Duties and Responsibilities

  • Ensure all Quality System documentation is accurate and comprehensive.
  • Initiate and update procedures, work instructions, forms, specifications and other applicable documentation.
  • Facilitate customer complaint activities throughout process to ensure complaints thoroughly investigated and closed in a timely manner.
  • Drive timely execution of the CAPA process through initiation, root cause investigation, corrective action plan, and verification of effectiveness.
  • Review and approve documentation: Changes initiated through change control process, validation protocols and reports, nonconforming dispositions, CAPA's and customer complaints.
  • Support pre-and post audit activities and facilitate closure of audit findings.
  • Maintain and control the document data base (initiation, approval, issuance and archiving).
  • Assist in assembling and maintaining technical file documentation to achieve CE Marking.
  • Coordinate product samples with outside testing laboratories such as: Biocompatibility, Accelerated Aging, and Transit.
  • Identify, monitor and report on quality metrics.
  • Develop and conduct training programs for personnel on Quality System requirements.
  • Identify areas of opportunity and support continual improvement of the Quality Management System.

Keywords: SunMed, Grand Rapids , Quality Specialist, Other , Grand Rapids, Michigan

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