MDSAP Technical Pack Reviewer Job at SGS, San Francisco, CA

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  • SGS
  • San Francisco, CA

Job Description

Be among the first 25 applicants two days ago. Get AI-powered advice on this job and access more exclusive features. Company Description We are SGS – the world's leading testing, inspection and certification company. Recognized as the global benchmark for sustainability, quality, and integrity, our 99,600 employees operate a network of 2,600 offices and laboratories worldwide. We aim to enable a better, safer, and more interconnected world. At SGS, we foster an open, international culture with a dynamic work environment. Our high professional standards and sustainability focus ensure a future-oriented workplace. We invest in our employees' long-term development, guided by principles like Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership. Job Description Main Purpose of Role Review MDSAP reports, approving or querying based on technical and procedural expertise. Ensure reviews are technically sound and compliant with all relevant regulations, standards, and guidelines. Provide high-quality service to meet customer requirements efficiently. Adhere to SGS policies, procedures, and processes. Part of the Global Medical Device Office (MDO) to minimize risks in medical device certification. Key Accountabilities Maintain current knowledge of MDSAP requirements, including jurisdictional standards, transmittals, and audit manuals. Understand the MDSAP grading system, CAPA procedures, and use of NGE forms. Review audit packs according to requirements and generate deficiency queries. Manage query corrections, submit final documents for approval, and ensure compliance with company standards. Participate in team meetings and contribute to KPIs achievement. Determine final approval of MDSAP packages and certificates, with signature authority. Ensure compliance with the company's Code of Integrity & Professional Conduct and policies on Equality & Diversity. Exercise due regard for health and safety at all times. Qualifications Skills & Knowledge Essential: Medical device knowledge, effective electronic communication, strong English writing skills, risk management understanding, customer focus, teamwork. Desirable: Experience with KPIs, workload planning, online systems. Experience Essential: Minimum four years in medical devices or related fields; MDSAP Lead Auditor experience; relevant university or technical degree; or equivalent knowledge. Desirable: Experience as a Medical Device audit Technical Reviewer; familiarity with regulatory jurisdictions. Additional Information Why SGS? Join a stable, global leader in TIC industry. Enjoy flexible working arrangements. Access continuous learning through SGS University. Collaborate globally in a diverse environment. Benefit from comprehensive benefits. We value diversity, teamwork, and the growth of our employees. Additional Details Seniority level: Mid-Senior level Employment type: Full-time Job function: Quality Assurance #J-18808-Ljbffr SGS

Job Tags

Full time, Worldwide, Flexible hours,

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