Analyst, Quality

Essential Functions

• Ensure Regulatory Compliance records are accurate complete and maintained in accordance with applicable requirements.
• Prepare review and maintain quality system and regulatory compliance documentation and records.
• Maintain and update compliancerelated database records.
• Support QMS document control processes.
• Assist with the creation maintenance and updating of training materials and training audiences.
• Identify discrepancies between metadata fields and approval records.
• Update required fields in Windchill to ensure alignment with approval records.
• Learn and effectively navigate electronic systems used to manage records and data.
• Demonstrate initiative to ensure work is completed accurately and thoroughly.
• Maintain organized detail oriented work practices.
• Assist in the development and execution of streamlined business systems to effectively identify and resolve quality issues.
• Apply sound systematic problem solving methodologies to identify prioritize communicate and resolve quality issues.
• Support company initiatives as directed by management and in alignment with the Quality Management System (QMS).
• Comply with U.S. Food and Drug Administration (FDA) regulations other applicable regulatory requirements company policies operating procedures processes and task assignments.
• Maintain positive professional communication and collaboration with employees customers contractors and vendors at all levels.
• Perform other related duties and responsibilities as assigned.

Experience

• 2 5 years of quality and/or regulatory experience or
• 2 years of relevant industrial experience typically within quality product development/support or scientific affairs functions.

Top Skills

• Working knowledge of regulations and standards affecting medical devices.
• Strong attention to detail and organizational skills.
• Ability to learn new systems and processes efficiently.

Education

• Bachelors degree preferred in Biotechnology Biology Chemistry Engineering or a related scientific discipline.