Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

Technical Manager, Medical Devices

SGS

Technical Manager, Medical Devices

Rutherford, NJ
Full Time
Paid
  • Responsibilities

    Job Description

    As the Technical Manager, Medical Devices, you will manage all technical reviews and inquiries for the SGS Knowledge medical device business sectors to ensure the quality of the service delivered meets internal, accreditation, and client requirements.  In addition to supporting business revenue growth, operational efficiency, and profitability, you will provide support in the management of client complaints, and internal and external findings.  

     

    • Manages a team of Auditors
    • Responsible for the Technical Management of SGS Knowledge Accredited & Non-Accredited Programs & related activities, while supporting business revenue growth, operational efficiency, and profitability
    • Manages all technical reviews and inquiries for SGS Knowledge business sectors to ensure the quality of the service delivered meets internal, accreditation, and client requirements
    • Provides support in the management of client complaints, and internal and external findings
    • Works effectively in a team environment with sales, auditors, and client service advisors to provide the highest level of support and responsiveness
    • Assist in recruitment by reviewing resumes or CVs and performing technical interview portion 
    • Develop new and or existing auditor training plan, on-boarding, procedure training, and calibration 
    • Support training new recruits for product knowledge
    • Monitor level one audit and review product qualification  
    • Perform Level One and Two audits 
    • Qualify and approve technical areas
    • Review technical and make decisions on the certification 
    • Review and approve all Proposal/Contract Worksheet 
    • Review and approve Certification Function Competence Review 
    • Attend Accreditation audit and visits 
    • Support Chargeable audits (Max 50% when needed, team need to discuss and agree) 
    • Sales Support product training 
    • Market product support
    • Involvement in mini projects and initiatives  
    • Ensure global KPI metrics are achieved (TRT, Queries, audit quality, etc) 
    • Handle and resolve appeal and complaints 
    • Continuous improvement for all MIRs
    • Adheres to internal standards, policies and procedures.
  • Qualifications

    Qualifications

    EDUCATION AND EXPERIENCE REQUIRED: 

    • Bachelor’s degree in related scientific discipline or equivalent industry experience 
    • Minimum 5 years of experience proven management function in the industry with minimum 4 years work experience in Medical Device Manufacturing. Advanced Degrees can substitute for some experience. Preference given to technical positions i.e., Design and Development or manufacturing 
    • Minimum 5 years auditing experience, Third Party Lead Auditor for ISO 13485, MDSAP, MDD, MDR
    • Minimum 3 year managing experience in auditing and certification business

    PREFERRED:

    • Knowledge of IVDD, IVDR and/or 3P510K

    LICENSES AND CERTIFICATIONS

    • Qualified in related standards
    • Completed Lead Auditor training for ISO related standards and another international standard as required

    KNOWLEDGE/ SKILLS/ ABILITIES

    • Language Skills: English Advanced Level of knowledge.  French or Spanish is a plus
    • Mathematical Skills: Intermediate preferred
    • Reasoning Skills/Abilities: Advanced level preferred
    • Computer Skills: Proficient in MS Office Suite is required
    • Analytical, decisive, adaptable, ethical, problem solver, persuasive, commercially sensitive, detail oriented.
    • Strong organizational and multi-tasking skills
    • Ability to operate without close supervision
    • Excellent client and internal communication skills
    • Strong understanding of customer and market dynamics and requirements. 
    • Excellent communication and interpersonal skills, at all levels 
    • Presentation skills
    • Able to interact with clients and public officials, at all levels 
    • Acts quickly and decisively; able to make tough calls.

    COMPUTER SKILLS

    • Proficient in MS Office Suite (Required)

    TRAVEL

    • Travels up to 50% of time; subject to change depending on business needs.  Some travel might be international.

    Additional Information

    SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.   To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required. 

    This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.    If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a call back.  Please note, this phone number is not for general employment information, but is only for individuals who are experiencing difficulty applying for a position due to a disability.

  • Industry
    Facilities Services