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Resources Qualification Manager For Medical Devices Certification

Join the LNE/G-MED team today
and work on the frontier of Medical Device Innovation!

 

Location(s): North Bethesda, MD
Contract Type: Perm Full-Time
Fields: Medical Device, In Vitro Diagnostics – Healthcare

About GMED North America

GMED North America is the US subsidiary of GMED, a leading Certification Organization, a distinguished Notified Body (CE0459) whose scope covers all of the existing European Medical Device Directives (90/385/EEC, 93/42/EEC and 98/79/EC) and 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 an important part of this process because their work directly influences GMED North America’s reputation. GMED North America is an Equal Employment Opportunity Employer.
We offer excellent benefits package including a group-sponsored health, dental and vision coverage, short-term and long-term disability, a company-matched 401k plan, a company paid life insurance, paid holidays and time off program providing our employees with great work-life balance.
We have currently an exciting opportunity for a Resources Qualification Manager for Medical Devices Certification position This position will report directly to the directors’ committee.

Job description

Summary

In partnership with the company Directors, the Resources Qualification Manager for Medical Devices Certification position will set strategy and goals for all aspects of talent acquisition and qualifications related to personnel.
His/ her role is to create and maintain a talent acquisition and qualification process, that meets the business needs, the regulatory and accreditation requirements of the subsidiary in synchronized and harmonized approach with the HQ talent acquisition team based in Europe, and in compliance of the state of art.
As a service provider, his/ her role is to develop a relationship with the hiring director and managers to understand the nuances of each role and to know how each specific opportunity fits into the overall team structures.

Essential Functions

1. Leads, mentors and develops the talent acquisition organization.
2. Establishes and maintains market and industry expertise including a comprehensive view of trends and competitors to help identify opportunities to improve talent acquisition results.
3. Researches, analyzes, prepares and presents talent acquisition reports and statistics.
4. Nurtures a pool of candidates for auditors, evaluators and other types of profiles, and evaluates their qualification’s opportunities based of the company’s needs and against the regulatory/ quality requirements.
5. Leads the qualification process for all existing profiles and maintains their qualifications and potential extensions.
6. Leads, mentors and develops the qualification organization accordingly to the Headquarter appropriate certification processes, and recommends improvements for the qualification process.
7. Organizes all needed meetings and events to maintain teams’ qualifications and state of the art practices
8. Leads and maintains a qualification tracking system for all candidates and personnel ensuring open channel of communication between various collaborators involved in the qualification process (internal and external resources).
9. Overviews and leads the qualification activities and supervises their progress in partnership with related Departments.
10. Is responsible for hiring, terminating, 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.

Qualifications and Education Requirements

1. Master’s degree in technical field related to medical or pharmaceutical.
2. Proven knowledge of the medical device regulation industry and functional expertise across multiple business units and an understanding of qualification processes and recruiting best practices.
3. Demonstrated success independently executing projects, targets and mid-term, long term objectives as well as leading people towards achieving targets and deliverables.
4. Strong stakeholder management and stakeholder engagement experience including influencing senior leaders.

Competencies

1. Business Acumen.
2. Excellent written and verbal communication skills.
3. Consultation skills.
4. Critical analysis.
5. Leadership & Navigation.
6. Strong Interpersonal Relationship Management skills.
7. Time and Project Management.
8. French required.

You are strongly encouraged to submit a copy your transcripts together with your resume and your application letter
Must be able to work without a need for Visa sponsorship
Send your application to hr@lne-gmed.com

 

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We serve your passion for progress in the Medical Device (MD) and In Vitro Diagnostics (IVD) industry from the United States

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