Join the GMED team today and work on the frontier of Medical Device Innovation!

The Qualification Unit Manager will set the qualifications strategy relating to the Certification team personnel (mainly Certification Project Manager(s), Medical Devices Auditor(s), Lead Auditors, Product Reviewers, Internal clinician) under different regulatory and normative schemes.

His/her role is to enhance a qualification process locally, that meets the business needs, the regulatory requirements of the subsidiary GMED North America with respect to GMED’s accreditation, and replicate the approach defined by the French Headquarter GMED whose scope covers the European Medical Devices Directives (90/385/EEC Active Implantable Medical Devices, 93/42/EEC Medical Devices and 98/79/EC In Vitro Medical Devices) and Regulations (MDR (EU) 2017/745 and IVDR (EU) 2017/746) as well as ISO 9001/13485, UKCA and MDSAP (Medical Device Single Audit Program).

His/her role is to develop a strong partnership with the different departments at GMED North America to capture the nuances of each role and assess how each specific opportunity fits into the overall team structures and growth.


Essential Functions

Qualification Management:

  • Deploy a highly efficient regulatory and technical screening process to quickly filter profiles brought by the HR department
  • Ensures the qualification process (initial qualification and renewal) for the existing and up-coming profile(s)
  • Defines and implements a strategy for the qualifications’ maintenance, renewal and extension of existing teams
  • Oversees and leads the qualification activities and supervises their progress in partnership with the related Departments (Certification, Operations, Human Resource(s) etc..).
  • In the framework of the procedures implemented by GMED Group, leads the improvement and the strengthening of the qualification local process, in terms of tasks flow, coordination, tools, and skills of involved stakeholders.
  • Supports and orients the development of a digital qualification managing system that streamlines and optimizes the process.
  • Ensures an active and collaborative partnership with the HQ Qualification department.

Qualification Unit Management:

  • Leads, mentors and develops the Qualification Unit: responsible for hiring, managing, training and developing, reviewing performance and administering corrective action for unit staff.
  • Communicates areas of accountability and performance expected of personnel assigned based on the given frame and the approved budget.
  • Analyzes and presents Qualification reports and statistics.

 


Who You Are

Required Education and Qualifications:

  • Bachelor’s degree in Sciences (Biotechnologies, Health related subjects, Biology, Chemistry…)
  • Demonstrates success independently executing projects, targets and mid-term, long term objectives, as well as leading people towards achieving targets and deliverables.
  • Minimum 3 years of work experience in project management in a fast-paced
  • Strong stakeholder management and experience influencing senior

Preferred Experience:

  • Proven knowledge of the European medical device Regulations and Medical Devices industry;
  • Functional expertise across multiple business units;
  • Understanding of qualification process(es) and recruiting best practice(s).
  • French language

Job-specific Competencies:

  • Strong capacity to understand complex processes
  • Business Acumen
  • Excellent written and verbal communication skills
  • Consultation skills
  • Critical analysis
  • Leadership
  • Strong Interpersonal Relationship Management skills
  • Time and Project Management
  • Solution oriented

Who We Are

GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) Authorized to act under European Regulation (EU) 2017/745 on medical devices, European Directives 90/385/EEC, 93/42/EEC, 98/79/EC and Regulation n° 722/2012 on products utilizing tissues of animal origin, GMED certifies a vast range of medical devices and in vitro diagnostic medical devices. An Auditing Organization Recognized by the MDSAP Regulatory Authority Council. We serve the Medical Device Industry with offices in Europe and the United States.

Our goal is to provide the best in Product Certification and Quality Management Services for Medical Device Manufacturers worldwide. At GMED North America, we strive to the highest standards of professionalism, competency, work ethic, and customer service. All our employees are the cornerstone of this process because their work directly influences GMED North America’s reputation.

Aside from our expertise and due diligence, we pride ourselves in our diverse workforces, with employees from different parts of the World.

Our Values:

  • Commitment to Clients and Patients’ safety
  • Expertise
  • Reliability
  • Team Work

What We Offer

We offer a competitive benefits package including group-sponsored health, dental and vision coverage, short-term and long-term disability, a 401k plan, company-paid life insurance, paid holidays, and a time off program providing our employees with a great work-life balance. We offer growth opportunities within the organization. There are a lot of opportunities and employees are able to apply and move into different roles within the company. We have numerous success stories, and we want you to be one of them.

GMED North America is an Equal Employment Opportunity Employer, committed to a diverse, inclusive, and healthy work environment with a unique culture.

Applicants responding to this posting must be able to provide proof of eligibility to work in the United States.

You are strongly encouraged to submit your resume and cover letter.

We look forward to hearing from you!