QMS Coordinator - Medical Program

Intertek • Boxborough, MA

1d • Remote

About The Position

Intertek, a leading provider of quality and safety solutions to many of the world’s top-recognized brands and companies, is actively seeking a Temporary 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.

Requirements

• High School Diploma or GED
• 2+ years administrative experience
• Technologically savvy and proficient with Microsoft Office suite
• Strong problem-solving skills
• Strong interpersonal skills
• Strong communication skills in both verbal and written formats
• Strong organization, time management and prioritization skills
• Ability to work independently in a fast-paced, multi-tasking environment with shifting priorities
• Strong analytical, organizational, communication and creative critical thinking skills
• This is a remote position; however, applicants must reside in and be able to legally work in the United States.

Nice To Haves

• 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.

Responsibilities

• Collaborate with clients and other functions within Intertek to support clients’ medical certification activities.
• Support certification programs including ISO 13485, MDSAP and ISO 9001
• 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.

Benefits

• 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.
• 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 [email protected] or call 1-877-694-8543 (option #5) to speak with a member of the HR Department.

What This Job Offers

• Career Level: Entry Level
• Education Level: High school or GED