Quality Assurance Engineer II

1 week ago


Manassas, Virginia, United States TalentBurst Full time

Job Overview: As a Quality Assurance Engineer, you will play a pivotal role in developing, modifying, and maintaining quality assessment systems and protocols for transforming raw materials into high-quality finished products. Your collaboration with engineering and manufacturing teams will be essential to uphold quality benchmarks.

Key Responsibilities:

  • Lead and engage in project teams to effectively implement enhancement initiatives or improvements in manufacturing processes.
  • Support manufacturing activities, including validation projects and equipment assessments, ensuring compliance with relevant regulations.
  • Participate in ongoing improvement and Performance Excellence initiatives, including leading, coaching, and facilitating project teams.
  • Provide technical support and direction to team members in enhancing Quality Systems.
  • Utilize quality engineering practices to assist project teams and manufacturing operations, employing tools such as Six Sigma, FMEA, and Control Plans.
  • Oversee the execution of validation protocols as needed.
  • Develop and update Quality Plans, including inspection processes, and train affected personnel.
  • Conduct technical reviews and analyze data for equipment and process performance accuracy.
  • Draft Technical Reports and Protocols, and review and revise Standard Operating Procedures (SOPs).
  • Interact regularly with colleagues, supervisors, and cross-functional teams.
  • Manage the change management program to ensure thorough technical reviews and risk assessments.
  • Oversee Corrective and Preventive Actions (CAPAs) to ensure effective resolutions.
  • Engage in Material Review Board (MRB) activities, ensuring thorough root cause analysis and appropriate corrective measures.
  • Analyze Quality System metrics and recommend corrective actions as necessary.

Performance Metrics:

  • Quality
  • Culture
  • Cost
  • Customer Satisfaction (Product Quality)
  • Continuous Improvement

Competencies:

  • People Skills: Quick learner, approachable, active listener, interpersonal savvy, patient, and perseverant.
  • Business Acumen: Action-oriented and customer-focused.
  • Leadership Qualities: Clear communication of team goals, expertise in project execution, and commitment to continuous improvement.

Qualifications:

Required:

  • Bachelor's degree in microbiology, chemistry, biology, engineering, or related fields with 4-7 years of relevant experience.
  • Ability to balance team and individual responsibilities.
  • Proficient in basic mathematical concepts applicable to practical situations.
  • Basic knowledge of Microsoft Word and Excel.
  • Detail-oriented with strong technical writing skills.
  • Able to work independently and collaboratively.

Desired:

  • Advanced degree in a relevant field.
  • Familiarity with regulatory standards such as cGMP, ISO 9001, and ISO 13485.
  • Certification as a Quality Engineer by ASQ.
  • Proven track record of delivering results.
  • Experience with Six Sigma and Lean methodologies.
  • Proficiency in statistical software such as Minitab and project management tools.


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