We are searching for a Quality Coordinator to join our growing team!

The Quality Coordinator will take ownership of the Quality Event Management System, including intake process, investigation coordination, resolution communication, associated procedures, training modules and software systems. This individual will work with all levels of the organization to ensure a robust complaint handling system is implemented and maintained across all product lines and that compliance-based reporting is generated accordingly.

The Quality Coordinator will manage the Quality System documentation review process. Working within Nipro’s eQMS, this individual will collaborate internally on department needs related to Quality System documentation, and support customer audits and regulatory authority inspections.

Responsibilities

• Owner of the Quality Event Management and Complaint Handling processes. This includes opening sample boxes for return to factory and completing the MDR evaluation.
• Manage regional Intake teams whose role is to enter customer-reported complaints from a variety of sources.
• Provide operational support to users of the complaint management process ensuring adherence to Nipro SOPs & Standards.
• Assist global business partners with the creation, review, escalation, and monitoring of complaints.
• Sustain and improve compliance of the Complaint Management Process by monitoring employee performance and training.
• Lead implementation of value-added improvements in collaboration with global stakeholders to achieve strategic Quality priorities.
• Collaborate closely with internal teams, customers, and manufacturing sites.
• Evaluate new or revised regulations for compliance gaps and support remediation efforts for gap closure.
• Create and update procedural documentation and work instructions with accuracy and clarity.
• Work within an electronic document control system cooperatively with other departments to ensure the needs of those departments for access to QS documents are met.
• Support the Quality department during customer audits and inspections by regulators, by ensuring documents are available upon request, and may be called upon to take notes during such activities.
• Provide training for new associates on Good Documentation Practices (GDP), Documentation requirements per internal procedures, and federal requirements.
• Assist Partner Solutions team and customers with Certificates of Compliance
• Assist with Quality reporting for Suppliers, manufacturing and company headquarters in Osaka, Japan.
• Assist with 3PL communication and reporting for non-conforming products, FDA Exams, Product Holds and Corrections and Removals, including recalls.
• Additional Quality responsibilities as needed.

Education & Experience

• High school diploma or GED required; college degree preferred.
• 1-3 years quality or regulatory experience in the medical device or pharma industry, desired. In lieu of experience, consideration is given for any experience with demonstrated knowledge of scientific principles or FDA regulated industry.

Skills/Knowledge Requirements

• Knowledge and understanding of US FDA 21 CFR Part 820, Part 803, and Part 807 is required.
• Knowledge and understanding of Canada medical device regulatory requirements is required.
• Knowledge of Document Control in a regulated environment is preferred.
• Familiarity with MasterControl software platform is a plus.
• Excellent computer proficiency (MS Office – Word, Excel, and Outlook)
• Excellent English verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Keen attention to detail and excellent time management skills.
• Ability to work independently and deliver results on time.
• Sense of urgency with the ability to prioritize tasks.

We offer a competitive salary plus benefits that include:

• Medical, Dental, Life Insurance and Employee Assistance Program
• Paid Time Off (Sick & Vacation), 18 Company paid holidays
• 401K plan with company match
• Employee Referral Bonus
• Open and team-oriented work atmosphere
• Career development and advancement opportunities