Configuration Management Associate - MDR

Teleflex

Maple Grove, MN, USA

Full time

Sep 19

About Teleflex Incorporated

Teleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people’s lives. We apply purpose driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine and respiratory care. Teleflex employees worldwide are united in the understanding that what we do every day makes a difference. For more information, please visit teleflex.com.


Global Operations - Global Operations is a complex and diverse organization within the company which is responsible for product fulfilment to all our customers from end to end. We pride ourselves on being totally Customer Centric in our unrelenting focus on Improving Quality, Service and Value as perceived by our customers. Our employees are dedicated to the Global Operations Enterprise Excellence journey. Join a dynamic, growing team that offers healthcare providers an array of medical technology solutions that make a difference in patients’ lives.

Position Summary

The Configuration Management Associate is responsible for supporting maintenance of product and business process change control and ensuring conformance to applicable MDR, QS and other applicable requirements. This position is also responsible for performing tasks that drive the timely release and change of product documentation and supporting data throughout the product’s lifecycle. This position will evaluate and process electronic change orders for completeness and adherence to procedure and will ensure accurate record retention of Quality System documents in accordance with defined requirements and procedures.

Principal Responsibilities

  • Facilitate the timely change, approval and release of product documentation and data (PLM, ERP)
  • Ensure all documents follow appropriate naming and numbering procedures
  • Support development of new product documentation and provide detailed reports, queries or summaries in support of various cross-functional projects and initiatives
  • Generate, assign, update and ensure accuracy of the Global Trade Identification Number (GTIN) information in the Data Sync Direct CRM
  • Partner with Regulatory and Integration teams to oversee and manage IFU-to-Web process and ensuring MDR regulatory requirements are met and maintained
  • Responsible for creation and submission of material master data in the ERP, ensuring alignment with Global Clearance Check team, Regulatory Operations team, Finance, Planning and Labeling and Packaging teams
  • Provide inventory control and maintenance of the central document reference library, including standards and guidelines
  • Administer the system for archiving and off-site storage of document control and data records in accordance with defined requirements
  • Provide high level customer service and support to specific cross-functional areas
  • Assist in monitoring process effectiveness including the impact of changes and take the initiative to recommend process improvements and assure procedures are in place to classify and maintain appropriate records
  • Apply best practices of change control and configuration management

MARGINAL RESPONSIBILITIES:

  • Participate in and/or lead special projects, as assigned
  • Provide audit and inspection support, as requested

Education / Experience Requirements

  • High School Diploma, or equivalent required.
  • Two years of relevant experience
  • Working knowledge of quality systems, compliance, and document control requirements in a regulated industry.

Specialized Skills / Other Requirements

  • Excellent written and oral communication skills
  • Working knowledge of quality systems and compliance in a regulated industry
  • Working knowledge of PLM and ERP software
  • Subject matter expert (SME) in change control and record retention processes
  • Detail oriented and self-directed with good time management skills
  • Ability to work collaboratively and independently
  • Ability to effectively execute projects and related activities with appropriate priority required
  • Ability to function as part of a team and achieve results through open collaboration with others
  • Results oriented with the ability to be accountable to the achievement of both individual and team goals

Working Conditions / Physical Demands

  • Typical office environment; exposure to unit lighting elements and computer monitors.
  • Essential and marginal functions require maintaining physical condition necessary for sitting, standing, or walking for prolonged periods of time during working day.
  • Persons performing service in this position classification will exert 10 pounds to lift, carry, push, pull and/or transfer equipment and materials; some reaching, stooping, bending, kneeling, and crouching occasionally required.
  • May rarely lift and stack heavy objects not to exceed 20 pounds; carry items up to 30 feet of distance.
  • Perceiving the nature of sound, near and far vision, depth perception, providing oral information; the manual dexterity to operate various office equipment; and other objects are an important aspect of the job.
  • Needs fine motor skills of hands and fingers to perform regular keyboarding throughout the day.
  • The job description documents the general nature and level of work but is not intended to be a comprehensive list of all activities, duties, and responsibilities required of job incumbents. Consequently, job incumbents may be asked to perform other duties as required.

Teleflex, Inc. is an affirmative action & equal opportunity employer. D/V/M/F. Applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at: 262-439-1894.

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