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Quality Systems Engineer III

LanceSoft Inc

  • Austin, TX
  • 30+ days ago
  • $40–$53.91 Per Hour

Highlights

Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA). Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.

Numbers & Facts

LocationAustin, TX
IndustryStaffing/Employment Agencies
Salary$40–$53.91 Per Hour
Company Size2,000 to 2,499 employees
Year Founded2000
Websitehttp://www.lancesoft.com/

Description

Title: Quality Systems Engineer III
Location: Austin, TX 78744 - Hybrid
Duration: 5+ Months

Hybrid - 3 days in office, 2 remote

Duties:
Job description:
  • Responsible for ensuring compliance with established requirements and standards for products and processes through effective implementation of the Quality Management System (QMS).
  • The position is responsible for supporting the global development, implementation, and continuous improvement and harmonization of the local Quality Management System (QMS) in compliance with applicable medical device regulations and standards, including FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR as well as corporate procedures and requirements.
  • What You Can Expect How You'll Create Impact Principal Duties and Responsibilities: Support cross-functional teams in the harmonization and standardization of quality procedures, tools, and best practices across sites and regions.
  • Complete gap assessments for local procedures against corporate procedures, requirements and applicable medical device regulations and standards. Collaborate with cross functional team members to align & execute updates to local procedures to align with applicable requirements.
  • This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Skills:
  • What Makes You Stand Out Expected Areas of Competence (i.e., knowledge, skills and abilities)
  • Extensive knowledge of global regulatory requirements for medical devices, including 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971.
  • Skilled in developing and implementing procedures for various QMS elements including but not limited to purchasing controls, design controls, nonconformance management, validation, and corrective and preventive actions (CAPA).
  • Familiarity with quality tools and methodologies (e.g., Six Sigma, root cause analysis, risk management, SPC, FMEA).
  • Strong communication and collaboration skills, with the ability to influence and drive alignment across diverse stakeholders (R&D and Regulatory).
  • Preferred experience with enterprise quality systems and ERP systems (e.g., SAP, EtQ). Must have previous Medical Device Experience
  • Preferred experience with SaMD (Software as a medical device) and class II medical devices.

Education/Experience Requirements
  • High school diploma or equivalent required.
  • Bachelor s degree in Engineering preferred.
  • Technical, engineering, and/or scientific background is strongly preferred.
  • Minimum 5+ years of experience in Quality/Regulatory Compliance or related field required
  • CQE or equivalent certification preferred.
  • Must be familiar with Microsoft Office Suite.

About Company

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

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