Technical Manager, Medical Devices
SGS North America Inc.

Company Description

SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 96,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.

Job Description

As the Technical Manager, Medical Devices, you will be responsible for the medical devices technical management of SGS Business Assurance Medical Devices accredited & non-accredited programs & related activities, while supporting business revenue growth, operational efficiency, and profitability. You will manage all technical reviews and inquiries for SGS Business Assurance Medical Devices business sectors to ensure the quality of the service delivered meets internal, accreditation, and client requirements. As the Technical Manager, you will provide support in the management of client complaints, and internal and external findings as well as providing management systems technical support to all SGS Business Assurance management, staff, clients, and other interested parties as required. You will work effectively in a team environment with sales, auditors, and client service advisors to provide the highest level of support and responsiveness.

• Manages a team of Auditors.
• Review, update, and ensure all parties are aware of the procedure requirements.
• 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 Proposal/Contract Worksheet
• Review and approve Certification Function Competence Review
• Support Chargeable audits/Training with minimum at 50% utilization.
• 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.
• Performs other duties as assigned.

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
• Knowledge of IVDD, IVDR and/or 3P510K is preferrable.
• Minimum 3 year managing experience in auditing and certification business.

Licenses/ 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
• 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.
• Works well under pressure
• Willingness to travel and work in a global team of professionals.

Travel

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

Benefits

• Salary - $120,000-$134,000/year (based on experience)

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.

All your information will be kept confidential according to EEO guidelines.

---