MDSAP Technical Pack Reviewer at SGS North America Inc. in Bloomfield, New Jersey

Job Description:

Company Description



We are SGS - the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.


At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.



Job Description




Main Purpose of Role

• To conduct reviews of MDSAP reports and approve or raise queries based on technical and procedural knowledge


• Ensure that reviews are technically sound and in compliance with all applicable regulations, standards, guidelines and Competent Authority expectations


• Ensure that the highest level of service is provided through efficient service delivery and that customer requirements are met


• Ensure adherence to SGS Policies, procedures and processes


• As a member of the Global Medical Device office (MDO) to minimise risks associated with medical device certification.

Key Accountabilities

• Maintain up-to-date understanding of MDSAP requirement, including all jurisdiction requirements, regulatory transmittals, MDSAP Audit Approach manual, and all associated standards


• Maintain up-to-date understanding of the MDSAP grading system, corrective and preventive action, and use of the NGE form


• Review MDSAP audit packs according to specified requirements


• Generate Query Sheets for any noted deficiencies in the MDSAP audit pack


• Review and accept/reject query corrections


• Submit final approved documents to the Global MDSAP administrator for submission to REPS


• Submit final approved document to the SGS system and approve the MDSAP pack


• Approve MDSAP certificates after technical approval.


• Participate in team meetings


• Maintain on-time reviews based on Regulatory requirements


• Participate in achievement of KPIs


• Determine final approval for MDSAP audit packages and the issue of MDSAP certificates


• Signature authority for final MDSAP reports and NGE


• If approved as an AO submitter, make submissions to REPS as required


• Ensure full compliance with the Company's Code of Integrity & Professional Conduct, and act in accordance with SGS UK's Equality & Diversity Policy and ensure others do so.


• At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company's policies and procedures.

Qualifications




Skills & Knowledge



Essential

• Medical device knowledge/codes


• Good communication techniques through electronic mediums


• Good written English skills (as reports will be reviewed/queried in English)


• Thorough understand of risk management systems and requirements


• Customer Focus


• Teamwork

Desirable

• Experience of working to KPI's


• Experience of planning own workload/priorities


• Ability to work with online systems

Experience



Essential

• Four years professional experience in the field of Medical Devices or related activities, (Advanced degrees can substitute for a maximum of three years of working experience)


• In exceptional cases, a demonstration of equivalent knowledge and skills may be acceptable.


• Previous MDSAP Lead Auditor Experience

Desirable

• Experience as Medical Device audit Technical Reviewer


• Previous experience working for regulatory jurisdictions or with regulatory requirements of any MDSAP Member country.

Qualifications



Essential

• Successful completion of a university or technical college degree or equivalent qualification in relevant studies e.g. medicine, science, pharmacy, engineering or other relevant sciences


• MDSAP Lead Auditor Qualification

Desirable

• Advanced degrees in engineering, science, or other relevant areas

Additional Information




Why SGS?

• Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.


• Enjoy a flexible schedule and work model.


• Access SGS University and Campus for continuous learning options.


• Thrive in a multinational environment, collaborating with colleagues from multiple continents.


• Benefit from our comprehensive benefits platform.

Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.

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