QMS Coordinator - Medical Program

Intertek CEA; Boxborough, Northern (MA, KY); Hybrid; USD 60,000 - 90,000; Full time

Benefits offered by this job

Remote work

401(k) with company match

Tuition reimbursement

Job summary

Intertek, a global leader in quality and safety, is seeking a Remote Medical Program Coordinator to support ISO 13485/MDSAP/MDR projects with clients and the Intertek Notified Body.

You will coordinate with internal teams and clients, manage documentation, and ensure compliance across certifications. The role requires strong analytical skills and experience with QMS systems, with remote work within the United States.

Qualifications

• Bachelor's degree required.
• 2+ years of experience with quality management systems.
• Strong analytical, organizational, communication and creative critical thinking skills.
• Remote work in the United States is allowed.

Responsibilities

• Collaborate with clients and Intertek teams to support medical certification activities.
• Support certification programs including ISO 13485, MDSAP, ISO 9001, ANSI/NSF 455 and ISO 22716.
• Coordinate with client and Intertek Medical Notified Body for MDR/EC activities.
• Address client questions, document requests, billing issues and disputes.
• Process changes affecting medical device certifications (address, scope, employee count, jurisdiction).
• Work with program management, auditors, scheduling, sales, finance and other functions to ensure compliant certifications.
• Manage an external database to ensure timely reporting to regulatory agencies and maintain shared email inbox.

Skills

Analytical skills

Organizational skills

Communication skills

MS Office

Quality Management Systems

Education

Bachelor's degree

Tools

Microsoft Office

Job description

Medical Program Coordinator – Remote

Intertek, a leading provider of quality and safety solutions to many of the world’s top-recognized brands and companies, is actively seeking a Medical Program Coordinator to join our Business Assurance team remotely. This is a fantastic opportunity to grow a versatile career in the medical device and third-party certification industries.

Intertek's Business Assurance team goes beyond testing, inspection and certification to look at the underlying elements that make a company and its products successful. Our assurance solutions provide confidence and total peace of mind that a client's operating procedures, systems and people are functioning properly to provide a competitive advantage in the marketplace.Intertek is continually innovating and evolving to reduce risk for consumers, brands and organizations in every sector and industry around the world.We go beyond Testing, Inspection and Certification of products: we are a Total Quality Assurance Provider to industries worldwide.Our Purpose: Bringing quality, safety, and sustainability to life.

What are we looking for?

The Medical Program Coordinator is responsible for collaborating with our clients and other functions, including our Medical Notified Body, to support their medical certification (ISO 13485/MDSAP/MDR) projects.

Salary & Benefits Information

• In addition to competitive compensation packages, when working with Intertek you can expect benefits including medical, dental, vision, life, disability, 401(k) with company match, generous vacation / sick time (PTO), tuition reimbursement and more.

What you’ll do:

• Collaborate with clients and other functions within Intertek to support clients’ medical certification activities.
• Support certification programs including ISO 13485, MDSAP, ISO 9001, ANSI/NSF 455 and ISO 22716.
• Coordinate efforts between client and Intertek Medical Notified Body as it pertains to MDR/EC certification activities.
• Deal with client technical questions, document requests, billing issues, and complaints/disputes.
• Process changes that affect medical device certifications (i.e., address, scope, employee count, and jurisdiction changes)
• Work with program management, auditors, scheduling, sales, finance, and other functions to ensure consistent and compliant medical certifications.
• Manage an external database to ensure timely reporting to regulatory agencies and manage a shared email inbox.

This position outline is a general guideline and does not represent all encompassing details. The position assumes that the incumbent has both the mental and physical requirements to carry out the above defined duties.

Minimum Requirements & Qualifications:

• Bachelor's Degree
• Strong analytical, organizational, communication and creative critical thinking skills
• Technologically savvy and proficient with Microsoft Office suite
• At least 2 years of experience with quality management systems
• This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Preferred Requirements & Qualifications:

• Work experience includes direct QMS responsibilities.
• Experience working for a medical device, pharma, cosmetics, and/or dietary supplement company.
• Experience working for a registrar/AO/Notified Body.

Intertek: Total Quality. Assured.

Intertek is a world leader in the Quality Assurance market, with a proven, high-quality business model and a global network of customer-focused operations and highly engaged subject matter experts. With passion, pace, and precision we work to exceed our customers’ expectations, while engaging with our employees to be 10X in their performance and professional growth.

Intertek is a drug-free workplace. As a condition of employment, certain positions may be required to pass a pre-employment drug test based on the type of work that will be performed.

We Value Diversity

Intertek’s network of phenomenal people are our greatest assets, and the diversity they bring fuels our success. Intertek is an Equal Employment Opportunity Employer that values inclusion and diversity. We take affirmative action to ensure all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other legally protected characteristics.

For individuals with disabilities who would like to request accommodation, or who need assistance applying, please email [e-mail] or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

#LI-JC1

#LI-REMOTE