OVERVIEW:
Being part of the Quality Systems & Compliance team means you are joining a team that wears many hats. From training new employees or resolving logistical problems, each day presents new challenges. We collaborate with every department, focused on enhancing efficiency and ensuring satisfaction for both internal and external customers, all while maintaining product quality, regulatory compliance and document control. Whether you're an experienced Quality professional or seeking a fresh opportunity, we invite you to join our dynamic and expanding team.
Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES: - You will develop a comprehensive understanding of all our products and devices while collaborating with cross-functional teams to ensure business continuity
- You will gain proficiency in using, troubleshooting, and support validation improvements for various electronic systems including (e.g. eQMS, SmartSheets, Microsoft Office, etc.)
- You will support the maintenance of quality compliance (e.g. Document Control, Employee Training, On/Off Boarding etc.)
- You will monitor and support compliance with standards, corporate policies and industry regulations.
- You will be challenged to find innovative and creative ways to improve and streamline practices and operations as our company grows.
- You will assist with internal and external audits.
REQUIRED KNOWLEDGE, SKILLS, AND ABILITIES: - Knowledge of quality systems and medical device compliance preferred
- Knowledge of ISO 13485, 11979, 14971, and 21 CFR 820/Part 11 preferred
- Individual with a curious and passionate mindset, keen on problem solving is detail-oriented
- Strong teamwork and communication skills with ability to collaborate across various disciplines and teams
- Capable of training others with diverse backgrounds and learning styles
- Strong adaptability and flexibility to handle daily changes
SUPERVISORY RESPONSIBILITIES: None
EDUCATION, EXPERIENCE, and TRAINING: - Minimum of 2-4 years of relevant work experience
- Microsoft Word; Microsoft Excel
- QAD and experience a plus
- Must be a US citizen or Permanent Resident of US (Green-card).
- Proficiency with Microsoft office tools
- Good decision-making, organization skills, problem-solving skills, and teamwork oriented
- Training to be completed per the training plan for this position as maintained in the document control system
CERTIFICATES, LICENSES, REGISTRATIONS: COMPUTER SKILLS: - You will be working within spreadsheets, documents, electronic systems.
Salary Description
$65,000 - $69,000 per year