Quality Systems Engineer

Company: Randstad USA
Location: San Diego
Posted on: November 9, 2024

Job Description:

Job Summary: The Quality Systems Engineer is responsible for developing and managing quality system controls within the SAP ERP system to ensure compliance in a regulated manufacturing environment, particularly in in-vitro diagnostics. 1st Shift- 8am-5pm HYBRID: on site at least 3 days per week Required:

• Experience: 0-2 years in quality assurance within a regulated environment; in-vitro diagnostic manufacturing experience is a plus.
• Regulatory Knowledge: Familiarity with standards such as 21 CFR 820, ISO 13485, and ISO 14971.
• Technical Skills: Understanding of quality controls within an ERP (preferably SAP).
• Communication: Skills in communication, facilitation, and negotiation.
• Adaptability: Ability to thrive in a fast-paced, dynamic environment with changing demands.Location: SAN DIEGO, CaliforniaJob Type: ContractSalary: $29.75 - 37.25 per hourWork Hours: 8am to 4pmEducation: BachelorsResponsibilities:
  • Quality System Governance:
    • Develop and enhance global quality system controls in SAP, including controls for raw materials, components, and finished products.
    • Global QMS Projects:
      • Lead QMS-related projects, from system transitions to integration, ensuring compliance with regulatory standards.
      • Use project management best practices to achieve and exceed objectives, involving relevant stakeholders for technical feasibility.
      • Cross-Functional Collaboration:
        • Communicate with quality stakeholders across sites to maintain alignment.
        • Engage SMEs to validate all Quality department ERP requirements and coordinate design reviews for processes and configurations.
        • Consultation and Problem Solving:
          • Provide expertise on quality plans, risk assessments, and remediation.
          • Apply systematic problem-solving methods to prioritize and resolve quality issues.Qualifications:
            • Experience Level: Experienced
            • Minimum 2 years of experience
            • Education: Bachelors (required)Skills:
              • Quality
              • ERP
              • SAP
              • ManufacturingEqual Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).This posting is open for thirty (30) days.
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Keywords: Randstad USA, Mission Viejo , Quality Systems Engineer, Other , San Diego, California