MDSAP Technical Pack Reviewer

SGS; Atlanta (GA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player seeks a dedicated professional to join their Quality Assurance team. In this pivotal role, you will conduct thorough reviews of MDSAP reports, ensuring compliance with regulations and maintaining the highest service levels. This position offers a dynamic work environment where you can grow your expertise while contributing to a safer, interconnected world. With a commitment to sustainability and integrity, the company fosters a supportive culture that values teamwork and diversity. If you have a background in medical devices and a passion for quality assurance, this opportunity is perfect for you.

Benefits

Flexible schedule

Access to SGS University for continuous learning

Comprehensive benefits platform

Qualifications

• Four years professional experience in Medical Devices or related activities.
• Successful completion of a relevant university degree.

Responsibilities

• Conduct reviews of MDSAP reports and ensure compliance with regulations.
• Participate in team meetings and maintain on-time reviews based on regulatory requirements.

Skills

Medical device knowledge/codes

Good communication techniques

Good written English skills

Thorough understanding of risk management systems

Customer Focus

Teamwork

Education

University or technical college degree in relevant studies

MDSAP Lead Auditor Qualification

Advanced degrees in engineering or science

Job description

1 week ago Be among the first 25 applicants

Company 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.
  
  

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.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Retail Office Equipment, Consumer Services, and Oil and Gas

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