Quality Assurance Engineer

2 weeks ago

Iowa City, Iowa, United States Crown Laboratories Full time
Job Overview

This role is pivotal in upholding the quality management system and crafting innovative solutions to quality challenges. It ensures adherence to quality control standards and protocols, guaranteeing that both incoming materials and finished products meet specified criteria. The position involves aiding in the formulation and execution of policies and procedures for assessing and validating the precision and reliability of products and/or equipment. Additionally, it supports Root Cause Analysis and Corrective Actions, ensuring timely and budget-conscious project completion. The role collaborates with the quality assurance team on various projects, tasks, and operational activities.

Key Responsibilities:
  • Align with organizational goals, objectives, policies, and procedures while adhering to quality systems, FDA regulations, and other relevant external regulatory standards.
  • Evaluate, recommend, and spearhead the implementation of systems, processes, and equipment enhancements to ensure compliance with cGMP and ISO 13485:2016 across Operations, Quality, and Regulatory functions. Document findings and recommendations thoroughly.
  • Provide quality engineering assistance to manufacturing and kitting operations, as well as support for new product introductions and transfers.
  • Design and execute quality control sampling systems, procedures, and statistical methodologies.
  • Conduct statistical data analysis and prepare technical documentation.
  • Maintain and communicate accurate project timelines.
  • Assist with various quality functions, including QA/QC sampling strategies, supplier development, and quality training programs.
  • Present data analysis and trend insights to management and relevant stakeholders as necessary.
  • Oversee the corrective action report process (CAPA), ensuring timely execution of necessary actions.
  • Investigate and review customer complaints in accordance with regulatory requirements, identifying trends and opportunities for corrective actions.
  • Ensure adherence to the Non-conformance process, providing technical insights and developing solutions for recurring issues.
  • Support internal, external, and corporate audit processes.
  • Analyze data to identify trends related to Nonconformance and Quality Holds, collaborating to devise innovative solutions.
  • Lead initiatives to resolve both recurring and new quality challenges, ensuring the production of safe and effective medical devices.
  • Work closely with Operations and R&D teams to establish and implement risk management, qualification, verification, and validation strategies.
  • Assist with Document Control initiatives and engage in continuous improvement activities related to the document control program.
  • Manage procedures related to the Device Master Record (DMR) and Device History File (DHF), supporting all activities associated with batch records and device history records (DHR).
  • Participate in maintaining Risk Management Files and contribute to Risk Analysis of changes, leading comprehensive risk assessments for product handling processes.
  • Support the management of Software Lifecycle requirements in accordance with IEC 62304.
  • Possess a robust background in electronics design and analysis, capable of interpreting schematics and conducting root cause analyses on circuits.
  • Perform additional tasks as required, in line with competencies.
Qualifications and Skills:
  • Bachelor's degree in Electronics Engineering is essential.
  • Experience in auditing quality assurance standards related to medical devices is required.
  • ISO 13485 Certified Lead Auditor or CQA certification is preferred.
  • Understanding of inputs, outputs, raw materials, waste management, quality control, costs, and optimization techniques for manufacturing and distribution.
  • Strong project management capabilities and the ability to manage multiple tasks effectively.
  • Proficient in report writing, business correspondence, and procedural documentation.
  • Ability to address inquiries or complaints from customers, regulatory bodies, or business associates effectively.
  • A minimum of five years of experience in quality engineering is preferred.
  • A minimum of three years of experience in the medical device sector is preferred.
  • Thorough understanding of FDA Quality System requirements, ISO 13485:2016, ISO 14971:2019, Medical Device Regulation (MDR), and Current Good Manufacturing Practices (cGMP).
  • Preferred familiarity with IEC 62304 Software Lifecycle requirements.
  • Proficient in Microsoft Office Suite, including Excel, Word, PowerPoint, and Outlook.
  • Experience with ETQ - Reliance and ROSS (ERP) systems is advantageous.
  • Exceptional attention to detail and strong communication skills, both written and verbal.
  • Good analytical and statistical problem-solving abilities.
  • High ethical standards are essential.
  • Willingness to travel up to 10% of the time.
Note: This job description serves as an overview of expected duties and qualifications. It is not intended to be a contract of employment, either explicit or implicit. All content is subject to change at the company's discretion, and cooperation from all employees is expected. Additional duties may be assigned as necessary.

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