Quality Assurance Coordinator - Medica Device

Supports multiple functions within the Crown Aesthetics organization by ensuring goals and priorities for assigned quality and business-related functions are met. This position focuses on the quality management system (QMS) and is responsible for establishing opportunities that promote growth, improvement, and compliance for product quality and corporate goals.

Responsibilities

• Perform thorough QA Review of individual incoming & kitting batch records prior to their release.
• Ensure that all QC Testing is complete and in place prior to batch release.
• Perform a review of Quality System for any open NCMs and CAPAs that may be related to the batch prior to release.
• Initiation, monitoring, and review of NCM and CAPA.
• Support risk assessments and failure mode investigations.
• Assist with KPI and metric generation.
• Continuous improvement data collection and recommendations.
• Provides support and direction for quality related topics.
• Ensures company’s adherence to cGMP, procedural requirements, and client specifications.
• Assist with internal and external certification audits.
• Ongoing monitoring of sterilization BI information from routine loads, environmental & bioburden audit info.
• Assist supplier quality with supplier monitoring.
• Maintain ongoing training and competency in assigned job function.
• Assist in the training and development of QA Specialists.
• Additional responsibilities will be assigned as necessary.

Requirements

• Strong understanding of the FDA, ISO, cGMP, etc., regulations and requirements.
• Minimum of 2 years’ experience in a manufacturing or quality assurance role, in a highly regulated industry (medical device or pharmaceutical) preferred.
• Experience with Lean and Six-Sigma methodologies — Green or Black Belt certification preferred.
• Understanding of quality audit process – internal auditor certification preferred.
• Familiarity with KPI and metric development and tracking.
• Successful interpersonal communication and meeting management skills.
• Excellent organization and PC skills.
• Must be able to work independently while demonstrating leadership and integrity qualities.

Qualifications

• Prefer a BS degree in a life science or engineering discipline (work experience may be considered in lieu of degree).

Schedule

Monday - Friday: 8:00am - 4:30pm

Benefits

• Competitive compensation including base salary and annual performance bonus.
• Paid time off, holidays, and floating holidays that can be used for whatever you choose.
• Generous healthcare benefits, Employer HSA match, 401k match, wellness discounts and much more.

Reporting to: QA Manager - Medical Device
Location: Plant