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Supervisor, Quality Assurance

Company: Sysmex North America, Inc
Location: Mundelein
Posted on: November 18, 2021

Job Description:

Overview Find a Better Way... ...to use your skills and experience.This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way....to improve the lives of others.Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory....to build a promising future. Responsibilities We currently have a great opportunity for a Supervisor, Quality Assurance. The Supervisor, Quality Assurance oversees and performs activities used to maintain quality processes required for medical device manufacturers and initial distributors including compliance with FDA, GMP, ISO, OSHA, and similar regulatory quality requirements. This position is responsible for identifyingkey process, product, and quality performance issues for products & services, and leads cross-functional teams within SAI and SRA to improve Quality process interactions with internal customers. Essential Duties and Responsibilities:

  • Leads the development and maintenance of key aspects in SAI/SRA Quality Systems, designed to meet the minimum regulatory and Quality requirements to assure compliance with FDA Quality Systems Regulations and ISO requirements.2. Responsible for the day to day Supervision, coordination, and completion of the following: a. Timely release of products; works closely with Manufacturing, Operations, Engineering, Quality Control, Service and other teams to ensure compliance to requirements for day-to-day activities. b. Review and approval of non-conformances, document control and document revisions as necessary. c. Lead collaborative and effective corrective and preventive (CAPA) actions and CAPA coordination throughout the company's quality systems. d. Prepare and oversee reporting activities including, tracking, documentation, documentation review, revision and approval. e. Development of procedures and controls in support of the Quality Management System. f. Customer Complaint Investigations (where applicable). g. Change Control activities within Product & Process Design Changes, Design Transfer, Document, and Supplier portions of the Quality Management System. h. Coordination of collaborative activities with Operations, Manufacturing, & Service functions such as periodic review of activities, process monitoring, procedure review, assistance with process mprovements.3. Performs and assists with internal audits and supplier audits as required to support the Quality System Audit program.4. Leads cross functional Quality Assurance teams to identify gaps and propose changesto processes that affect quality systems compliance. Executes overall projectmanagement and is able to complete most work independently.5. Drives company deployment of Quality System processes and procedures andpromotes ongoing education of the company's knowledge of the Quality System andregulatory requirements.6. Fosters an environment of continuous quality management improvement.7. Displays a positive, can-do attitude and assists colleagues with quality system problemidentification, management and correction/prevention.8. Other duties as requested Travel Percentage: 25% Physical Risk: Regular exposures to risk that may require special training and precautions. Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions. Qualifications
  • Bachelor's degree and 7 years required experience in Medical Device Quality Assurance / Quality Systems including experience in the Armed Forces. Bachelor's degree with a specialization in Biological / Chemical Sciences _ preferred.
  • 5-10 years total career experience. Knowledge of cGMP (FDA QSR) and ISO regulations.
  • English.
  • Strong Microsoft Word, Outlook, Excel, Power Point, Access
  • Strong communication and interpersonal skills.
  • Ability to obtain cooperation, develop a consensus and lead or influence crossfunctionalteams.
  • Positive "can do" attitude, able to foster an environment of continuousimprovement.
  • Strong analytical skills and problem solving ability. Sysmex's COVID-19 vaccination policy, consistent with its status as a federal government contractor and commitment to its customers and to providing a safe workplace for its employees, requires that, to the extent permitted by applicable law, all Sysmex employees must be fully vaccinated against COVID-19 by the latter of your start date or December 1, 2021. To the extent permitted by applicable law, any offer of employment extended will be conditioned upon the individual's ability to provide proof of current vaccination status. Sysmex makes reasonable accommodations when needed for medical or religious reasons. However, vaccine exemption and other accommodation requests cannot be granted unless the individual is able, with the accommodation, to perform the essential functions of the job. Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

Keywords: Sysmex North America, Inc, Arlington Heights , Supervisor, Quality Assurance, Other , Mundelein, Illinois

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