Job Title: Quality Management Systems (QMS) Specialist – Medical Devices
Location: Austin, TX 78744 (Hybrid – 3 days onsite)
Pay Rate: $52–54/hour

Position Overview
We are seeking an experienced QMS Specialist to support the development, implementation, and continuous improvement of Quality Management Systems within a regulated medical device environment. This role plays a key part in ensuring compliance with global regulatory standards while driving harmonization of quality processes across sites and regions.

Key Responsibilities
Support cross-functional teams in standardizing and harmonizing quality procedures, tools, and best practices across global locations
Conduct gap assessments comparing local procedures against corporate standards and regulatory requirements
Partner with stakeholders to align and execute updates to procedures to ensure compliance
Contribute to the ongoing development and continuous improvement of the Quality Management System (QMS)
Ensure compliance with applicable regulations and standards, including:
FDA 21 CFR Part 820
ISO 13485
IEC 62304
EU MDR
Collaborate with R&D, Regulatory, and other functional teams to drive alignment and quality excellence

Required Qualifications
Minimum 5+ years of experience in Quality, Regulatory Compliance, or related field within the medical device industry
Strong working knowledge of global medical device regulations (21 CFR Part 820, ISO 13485, EU MDR, ISO 14971)
Experience developing and implementing QMS procedures such as:
Design controls
Purchasing controls
CAPA
Nonconformance management
Validation processes
Proficiency with quality tools and methodologies (Six Sigma, root cause analysis, FMEA, SPC, risk management)
Strong communication and collaboration skills with the ability to influence cross-functional teams
Experience with enterprise quality systems and ERP platforms (e.g., SAP, EtQ) preferred
Prior experience with Software as a Medical Device (SaMD) and/or Class II medical devices is a plus
Proficient in Microsoft Office Suite
Education
High school diploma or equivalent required
Bachelor’s degree in Engineering or a technical/scientific field preferred
CQE or equivalent certification preferred

Equal Opportunity Employer / Disabled / Protected Veterans

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The pay transparency policy is available here:
https://www.dol.gov/sites/dolgov/files/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf

For temporary assignments lasting 13 weeks or longer, AppleOne is pleased to offer major medical, dental, vision, 401k and any statutory sick pay where required.

We are committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation for any part of the employment process, please contact your staffing representative who will reach out to our HR team.

AppleOne participates in the E-Verify program in certain locations as required by law. Learn more about the E-Verify program.
https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster_ES.pdf

We also consider for employment qualified applicants regardless of criminal histories, consistent with legal requirements, including, if applicable, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance. Pursuant to applicable state and municipal Fair Chance Laws and Ordinances, we will consider for employment-qualified applicants with arrest and conviction records, including, if applicable, the San Francisco Fair Chance Ordinance. For Los Angeles, CA applicants: Qualified applications with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.