Quality Assurance Associate, Quality Systems

Description

Job Purpose

The role of the Quality Assurance Associate with a focus on quality systems is primarily responsible for quality assurance (QA) review and approvals to ensure only high-quality products are released to our customers. This associate will be responsible for daily reviews and approvals of products, the activities that address quality system implementation and alignment, nonconformity and CAPA program effectiveness, and serve as a liaison across the organization to promote a quality culture.

Key Duties And Responsibilities

QA review and approval of products and systems

• Perform quality assurance (QA) review and/or approval of items (incoming, WIP, finished goods) focusing on job and material transactions, test results, and complete documentation prior to materials being placed into inventory.
• Perform QA review and approval of monthly, quarterly, and yearly calibration testing and verification.
• Review equipment qualifications and maintenance schedules/reports.
• Review initial and final supplier qualifications, as needed.
  
  

Support and execute QA processes

• Contribute to the operation, maintenance, and improvement of IMMY’s Quality Management System (QMS).
• Nonconformities: Collaborate across departments to ensure containment and disposition actions are documented; review nonconformities for accuracy and completeness; and monitor nonconformities to ensure timely closure of issues.
• Corrective and Preventive Actions (CAPAs): Organize CAPA meetings and discussions; perform investigations and assist in root cause analysis; develop action plans to drive projects to closure; and monitor CAPAs to ensure timely completion of projects.
• Track due dates/close out times for MRRs, CAPAs, and customer complaints to meet quality objectives.
• Prepare internal audit checklists, assist in internal auditing, and draft audit reports based on the audit results.
• Participate in external audits, as needed.
• Execute document and change control (ECNs), as needed.
• Collaborate with team members to gather and analyze quality related data, compile results for quality reports, recommend actions, and identify new and temporary quality objectives.
• Collaborate across the organization to ensure compliance requirements are met and encourage a culture of quality.
• Must demonstrate commitment to the development, implementation, and effectiveness of the QMS per ISO, FDA, and other regulatory agencies.
  
  

Support and execute post-market surveillance (PMS) and risk management requirements

• Assist in developing PMS and post-market performance follow-up (PMPF) plans.
• Assist in executing PMS and PMPF plans, as needed.
• Assist in drafting PMS reports, periodic safety update reports (PSURs), and summaries of safety and performance (SSPs).
• Assist in maintaining risk management files and reports.
• Frequent use of Microsoft Office applications, quality management software, and ERP software.
• Must comply with all company policies, procedures, internal and external quality standards, and relevant regulatory standards; must remain up to date on Quality Regulations and ISO Standards.
• Other duties as assigned.
  
  

The Individual

Required Qualifications

• Bachelor’s degree in Science, Engineering, or Business or a combination of other education/job related experience.
• Skilled in Microsoft Applications including Word and Excel.
• Must have professional behavior, and excellent verbal, interpersonal, and written communication skills to effectively interact with management, multiple departments, and outside agencies.
• Must be able to work independently and as part of a team, be extremely organized with a high attention to detail, and have excellent time management skills to meet tight deadlines.
• Desired Qualifications:
• Experience working in an established ISO 13485, EU IVDR, and FDA quality regulated environment.
• ISO 13485 and/or internal auditor certification.
  
  

Equal Opportunity Employment: IMMY is committed to the principle of equal employment opportunity for all employees and applicants for employment and prohibits discrimination and harassment of any kind without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, and local laws. IMMY will not tolerate discrimination or harassment based on any of these characteristics. This policy applies to all terms and conditions of employment, including, but not limited to, recruiting, hiring, promotion, termination, leaves of absence, compensation, and training.

Background Check Policy: All offers of employment at IMMY are contingent upon clear, acceptable results of a thorough background check. IMMY performs all background checks in compliance with EEOC and FCRA regulations and all other applicable federal, state, and local laws.