Quality Assurance Specialist

1 month ago

Ball Ground, United States MVE Biological Solutions Full time

The Quality Specialist is responsible for organizing, planning, and directing activities related to the development, application and maintenance of quality standards for industrial processes, materials, and products. The Quality Specialist supports the Quality Assurance department by continuously maintaining and improving the Quality System in compliance with applicable regulations and standards. This individual assures compliance with applicable medical device regulations, guidance and standards for jurisdictions where devices are marketed and assists in creation and maintenance of documents required to demonstrate compliance to medical device regulations.


PRIMARY RESPONSIBILITIES (include but not limited to):

  • Provide daily quality system support activities.
  • Support MVE Training program.
  • Provide support in all internal, external, and supplier audit activities.
  • Participate in continuous improvement projects as needed.
  • Implement & maintain policies and procedures to ensure continuous compliance to MVE’s Quality Management System.
  • Implement quality strategies for modified and new product development.
  • Implement methods and systems to assure that MVE’s development and manufacturing teams receive support in the areas of risk management, design controls including validation and verification testing, corrective and preventative action, root cause analysis, statistical analysis, quality planning and inspection processes.
  • Oversee product and manufacturing changes (Change Control) for compliance with applicable regulations and potential impact on future and current regulatory submissions.
  • Participate in the product development process to assure products are designed in compliance with the appropriate regulations and applicable international quality systems standards.
  • Implement Quality Systems metrics and evaluation processes and reporting of these metrics to MVE Management Team.


COMPETENCIES & PERSONAL ATTRIBUTES:

  • Establishing and maintaining Key Performance Indicators.
  • Problem solving with a clear understanding of compliance requirements and the ability to collect objective evidence for investigations can help solve problems, typically in situations where general standardization should exist, but may not be operating effectively.
  • Team player with the ability and willingness to be involved in teams and meetings at every level of the organization.
  • Passion for, and alignment with, MVE’s mission.
  • An individual who brings strong core values, quality, ethics, and integrity.
  • A team player who embraces and champions the culture of collaboration and accountability.
  • Strong work ethic and ability to deliver results and meet commitments in a dynamic environment.
  • Exceptional and dynamic communication skills with the ability to inspire and influence others
  • An individual who works independently, efficiently, and effectively prioritizes and drives towards our corporate goals.
  • Desire to make own decisions and take responsibility for outcomes.
  • Willingness to travel when required.


QUALIFICATIONS AND EDUCATIONAL REQUIREMENTS:

  • Bachelor’s Degree in an engineering field or other technical science.
  • 5 years prior experience in Quality Assurance and Regulatory Affairs.
  • Strong attention to detail.
  • Demonstrated experience working with regulatory bodies, contract manufacturers, suppliers, and distributors.
  • Comfortable working within a fast growth and changing environment.
  • Demonstrated ability to effectively communicate and influence decision makers.
  • Experience in quality systems and audits.
  • Knowledge of various Quality System and Regulatory Standards that are applicable to GMP Compliance.
  • Experience working in cross functional organizations.
  • Strong communication and interpersonal skills.
  • Excellent written and verbal communication skills with the ability to listen, articulate and advocate.
  • Proactive, high-performance result oriented and manage projects with ethical integrity.
  • Manage multiple projects and deadlines.
  • Ability to identify compliance risks and escalate when necessary.
  • Demonstrate both creative and critical thinking skills
  • Hold a Six Sigma Green Belt or Black Belt or willingness to work towards attainment.
  • ASQ Certified Quality Engineer (CQE) and Certified Quality Auditor (CQA) preferred.
  • Advanced training/experience in the use of statistical techniques and process improvement methods.


PREFERRED SKILLS:

  • Excellent computer skills including Microsoft office suite of products (Word, PowerPoint, Excel, etc.).
  • Understanding of GMP regulations.
  • Experience with IATA DG regulations, specifically Class 6.2, Conformite Europeenne requirements, etc.
  • Experience with EDMS systems and implementation.

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