Date Posted: 06/02/2025
Hiring Organization: Rose International
Position Number: 483572
Industry: Medical Equipment & Supplies
Job Title: Staff Quality Management Specialist
Job Location: Portage, MI, USA, 49002
Work Model: Onsite
Employment Type: Temporary
FT/PT: Full-Time
Estimated Duration (In months): 20
Min Hourly Rate($): 52.00
Max Hourly Rate($): 58.00
Must Have Skills/Attributes: Medical device, Quality Management, Regulatory Affairs
Experience Desired: Medical device labeling (6 yrs)
Required Minimum Education: Bachelor’s Degree
Job Description
Required Education:
• Bachelor’s degree
Required Qualifications/Skills/Experience:
• Minimum of 6 years' experience in medical device labeling or regulated industries
• Proficiency in label management and desktop publishing software
• Familiarity with global regulatory labeling requirements and standards
Overview:
Under minimal supervision, develops and maintains labels for medical devices. Collaborates with product subject matter experts to gather and assess labeling content. Executes label format and compiles content using specialized software. Audience for labels includes hospital and healthcare staff in global markets. Labels must comply with medical device regulations, standards, and business requirements.
Job Duties:
• Collaborate with product SMEs to assess and determine label requirements and content: Regulatory Affairs, Product Development, Product Safety Engineering, Packaging Engineers, Clinical Sciences, Marketing, Trade Compliance, etc.
• Participate in new product label planning meetings and capture requirements using quality system planning documents
• Design label formats for functional usability by healthcare staff
• Use specialized labeling software to generate templates and enter label data, text, and graphics into label database for print-on-demand label system
• Use desktop publishing software to design labels produced by external suppliers
• Ensure barcodes pass verification testing
• Select appropriate label materials for labels applied to packages and products in collaboration with packaging engineers
• As needed, support label translation strategies that satisfy international labeling needs
• Support multiple concurrent labeling projects for new products and label maintenance
• Review labels for completeness and presentation including labels created by others
• Contact external suppliers to resolve label output details.
• Manage labels in PLM/CMS system for controlled label releases and revision management.
• Manage work to meet project milestones.
• Inform project managers of relevant aspects of language translation and impact to label design.
• Communicate impact of language translation for alignment with project timelines and cost
• Collect and track data/metrics associated with projects
• Provide reviews of regulatory documentation to ensure that medical device labeling references are complete and correct and compliant with FDA and EU requirements
Industry:
• Medical Technology
Estimated Start Date:
• 6/23/2025 - **Only those lawfully authorized to work in the designated country associated with the position will be considered.**
- **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**
Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.
California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.
Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.
If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.
Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).
Rose International maintained good communication during assignments and are very informative through email and phone calls.
Sade, Consultant
Your team at Rose International is always very helpful and responsive.
Barbara, Consultant
Working for Rose International was the most pleasant assignment I have ever had. They were always on top of situations when necessary, and very helpful. I was very proud to be an employee of Rose International, and would recommend anyone to try to work with them.
Melvon, Consultant
My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.
Diana, Consultant
As a contractor, I have to say that Rose International was by far the best agency I have worked for.
Q'testdalir, Consultant
EMPLOYEE COMMENTS