Quality Assurance Associate

At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company.

We are seeking a QA Associate to join our team. The position will support Quality Assurance department in maintaining, improving and ensuring compliance of specific quality system elements including Customer Complaints, CAPAs, Variances, NCMRs, Internal and external Audits.

The QA Associate will also assist with the maintenance of the Calibration Program and assist with other Quality Assurance activities.

Essential Duties and Responsibilities (includes but not limited to):

Customer Complaints

· Log complaints and create complaint files: track and monitor complaints;

· Review and evaluate complaints appropriate actions

· Lead cross-departmental efforts to resolve customer concerns and questions

· Forward complaints, complaint information and customer samples to investigation sites(s);

· Ability to perform initial technical evaluation of products returned for complaint investigation.

· Support investigation by gathering additional information, if necessary

· Review and approve Root Cause investigation and Risk Analysis

CAPAs

· Assist with maintenance of the CAPA program.

· Track and follow up on Corrective Action/Preventive Actions (CAPAs);

· Support trending and analysis of CAPA data

· Reviews CAPA files for completeness and accuracy and ensures the required documentation supports closure of CAPAs

Audits

· Facilitates and participates in Internal and External Quality Audits.

· Participation in external audits as SME for Customer Complaints, Internal Audit, and CAPAs

Other

· Maintain calibration schedule and ensure activities are completed per schedule

· Conduct Quality Management System trainings

· Conduct DHR review if needed

· Assist with NCMRs

· Assist with the variance program

· Support Management Review meetings

· Other duties may be assigned

Supervisory Responsibilities

· May supervise others

Education and/or Experience

· Requires a Bachelor's Degree in life science or equivalent combination of education and relevant work experience.

· Minimum of 2 years' related experience in Quality Assurance with a minimum of 2 years industry experience (IVD, Medical Devices).

Required Knowledge, Skills and Abilities

• Working knowledge of QMSR & ISO 13485:2016;
• Strong organization, communication, and record-keeping skills.
• Ability to multi-task, prioritize and manage time effectively.
• Must have strong oral and written communication skills.
• Familiarity with root cause investigations is preferred.

The salary range for this position takes into