Quality Assurance Manager jobs in United States
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SGS · 1 day ago

Quality Assurance Manager

SGS is the world's leading testing, inspection and certification company, recognized for sustainability, quality, and integrity. The Quality Assurance Manager will develop and administrate the quality system based on ISO/IEC 17025 and ensure compliance during the equipment qualification process while promoting continuous improvement of laboratory systems.

OutsourcingSkill AssessmentTest and Measurement
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H1B Sponsor Likelynote

Responsibilities

Lead the ISO/IEC 17025 and 21 CFR, Parts 11, 210, 211, 610 and 820 Quality System at SGS North America Inc. as a system of continuous improvement
Responsible for ensuring IT, Facilities, and the Labs are 21 CFR Part 11 Complaint during equipment qualification process and through regular data integrity audits
Ensure that all registrations and certifications for the lab remain current
Give leadership and develop the quality system with the Qualtrax Document Management System as a tool for achieving ISO/IEC 17025 requirements and the cGMP compliance in Christiansburg
Provide quality approval for all documentation related to work instructions
Provide one of two approvals for all approvals related to Quality Procedures or major system changes
Lead and administer the Qualtrax Document Management system
Oversee the schedule, training, execution and, closing of the Internal Audits each year
Oversee all non-conformances resulting from Internal and External Audits, Complaints, OOS’s and any other investigations ensuring that the system is suitable for compliance and business practice
Execute all quality agreements or quality surveys sent by the customer
Lead all customer audits, or regulatory body audits representing SGS North America Inc. and providing the required documentation, interaction, and completion of any resulting actions
Interact with all lab staff as necessary to ensure that all quality requirements are understood and executed through effective communication and training
Oversee the Quality Control System including leadership of any changes or improvements
Lead Root Cause Analysis to identify and eliminate sources of non-conformances / lab errors
Manage all Proficiency Testing to help support ISO/IEC 17025 accreditation
Conduct Management Reviews for local lab leadership to promote continuous improvement and adherence to Quality System

Qualification

ISO/IEC 1702521 CFR ComplianceQuality System ManagementQualtrax Document ManagementAdvanced Chemical TechniquesFDA Regulated EnvironmentMathematicsAdvanced Reasoning SkillsMS OfficeQuality System SoftwareEnglish LanguageVerbal CommunicationWritten CommunicationInterpersonal Skills

Required

Bachelor's degree in a related field
Minimum 5 years of experience in a Quality Assurance role

Preferred

Bachelor's degree in chemistry or related field
4 years of experience in Chemistry or related field
Experience working in an ISO/IEC 17025 and/or cGMP environment
Experience working in an FDA regulated environment
Experience with pharmaceutical and medical device manufacture or testing

Benefits

Medical, dental and vision insurance, life insurance, employee wellness programs
Competitive pay, 401(k) with company match (immediate vesting upon enrollment), employee referral program
Online training courses, virtual and classroom development experiences, tuition reimbursement program
Paid-time off (vacation, sick, company holidays, floating holidays, volunteer time)

Company

SGS is the inspection, verification, testing and certification company.

H1B Sponsorship

SGS has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (19)
2024 (9)
2023 (13)
2022 (15)
2021 (18)
2020 (19)

Funding

Current Stage
Public Company
Total Funding
unknown
2023-04-12IPO

Leadership Team

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David Schramm
Operations Manager
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Janet Vergis
Board Director
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Company data provided by crunchbase