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Job Title:  Associate Label Designer/Document Control Coordinator

Req ID:  18950
Job Category:  Regulatory Affairs
Country/Region:  US
State:  OH
City:  Mentor
Zip:  44060
Description: 

At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

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Position Summary

he scope of this position for the associate label designer includes development of labeling and artwork for products under authority of the STERIS Endoscopy business unit.  The products included are produced both internally on-site and externally by third party contract packagers.  This position provides assistance and support in artwork development, revision control, release for production, and revision archives.  Graphics compliance with Corporate and Business Group graphic identity standards and guidelines is critical.  The resulting graphics must promote safe product utilization, satisfy external and internal customer needs, project appropriate STERIS visual image and high quality, and be cost effective and functional.  Position will function within a World Class Safety culture.  The scope for the document control coordinator is to insure quality system compliance, design control and product traceability, which are critical aspects to the development, manufacture and distribution of medical devices that ensure patient safety and product performance.  This position requires a self-starter with excellent time management skills, organization and attention to detail.  The person in this role must have the ability to apply company document and change control standards and be able to communicate internal document and change control practices to others.

Duties
  1. Practice a World Class Safety philosophy on and off the job. 
  2. Assist and support design, development, coordination of artwork that satisfies the varied needs of the Marketing, Regulatory, Manufacturing, Product Development, Package Design, and other related functional areas.  The graphics content is supplied and approved by Marketing, Clinical and Quality, and Regulatory areas. 
  3. Develop and maintain product labeling in compliance with Corporate and Business Group graphic identity standards and guidelines, and in compliance with federal, state, and local laws, and global requirements as applicable.
  4. Knowledge and understanding of US FDA, EU MDD/MDR and UDI labeling regulations, and ability to stay abreast of change to global medical device regulations.
  5. Maintain computer systems including the labeling software system and Macola, and support manufacturing operations.
Duties - cont'd
  1. Develop and maintain graphics artwork tracking systems, including databases, to facilitate project scope development, creation, planning, execution, tracking and status reporting.  Maintain appropriate graphic artwork archival records systems. 
  2. Maintain work instructions associated with the labeling processes and review production labeling SOPs, in order to identify and implement improvements including accuracy, and reduction of non-valued added effort.
  3. Lead new label and labeling redesign or enhancement projects.
  4. Requires positive individual and cross-functional team contacts, including with contributors in many functional areas, such as Marketing, Project Management, Product Development, Purchasing, Quality Systems, Manufacturing, Packaging Development, contract packagers, and packaging manufacturers.
  5. Knowledge of FDA and ISO 13485 standards and other relevant requirements.
  6. Support and assist regulatory and document control specialist in the generation and processing of documentation.
  7. Maintain database systems: PLM, Nicelabel and ERP (BOM and part), Excel.
  8. Coordinates Retention for Document Control records following corporate procedures.
  9. Performs quarterly audits on the production floor.
Education Degree
  • Bachelor's Degree
  • High School Diploma or GED
Required Experience
  1. 1 year of Pharmaceutical and/or Medical Device industry experience in the labeling field is required.
  2. 1+ years experience with Nicel Label.
  3. Position will require excellent verbal and written communication skills.
  4. Strong attention to detail.
  5. Excellent proofreading skills are required.
  6. Ability to handle numerous project at a given time, will strong organizational skills.
  7. Independent work ethic, that can organize work in an efficient manner and make decisions on layout and design, staying within the STERIS Corporate graphic identity standards.
  8. Proficiency in Windows Office Suite is required.
  9. Working knowledge of NiceLabel software is preferred.
  10. Working knowledge of Macola and Oracle is preferred.
  11. Working knowledge of PLM software is preferred.
  12. Excellent organizational skills are required.
  13. Work is primarily performed in an office environment, with additional work and production support performed in a manufacturing environment.

 

STERIS is a $3B, publicly traded (NYSE: STE) organization with approximately 12,000 associates worldwide and operates in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.


Nearest Major Market: Cleveland
Nearest Secondary Market: Akron

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