Description

You will manage quality assurance and compliance within a cGMP environment, ensuring on-time delivery of results and maintaining rigorous standards.

Responsibilities

• Manage change processes and drive independent decision-making within the quality framework.
• Utilize statistics to perform data trending and interpretation for continuous improvement.
• Execute project management tasks to ensure timely delivery of quality outcomes.
• Mentor and coach team members while presenting findings to stakeholders.
• Produce technical writing documentation for quality processes and compliance requirements.

Required Skills

• 3+ years of experience in a cGMP Quality Assurance or Compliance environment.
• Bachelor’s degree in engineering or an applicable science/technology program.
• Proficiency with Microsoft Office tools, specifically Excel.
• Experience with statistical analysis for data interpretation.
• Strong technical writing capabilities.
• Proven project management skills.
• Ability to lead and manage through change.

Preferred Skills

• Experience in a medical device environment.
• Proficiency with Minitab or equivalent statistical software.

Key Skills

Education

Bachelor's degree