Process Quality Engineer I
Summary: The contractor will work closely with cross-functional teams to revise existing procedures and develop new documentation in compliance with FDA, ISO 13485, and EU MDR requirements.
Key Focus Points:
- Ensure that documentation follows best practices for clarity, accuracy, and compliance.
- Review and update existing quality management system procedures to align with current business standards, policy, practices and regulatory requirements (MDR, FDA, ISO 13485).
- Collaborate with engineering, production, operations, purchasing, and quality teams to gather input and draft new procedures, work instructions, and forms.
- Assist in harmonizing quality management system documentation as part of ongoing quality system improvements.
- Support gap assessments and corrective actions related to procedural compliance.
- Participate in document control processes, ensuring proper approvals and version control.
Requirements:
- 1-2 years background in quality and/or procedure writing that would be a bonus.
- Driven yet flexible and ope to change
- Experience with writing work instruction
- Proficiency in Microsoft Office (Word, Excel, PowerPoint); experience with document control systems preferred.
- Must be detail oriented and proficient in writing skills
6 month contract
Monday through Friday 8am-5pm
Pay=$30/hr-$35/hr
Location: 80907
