Quality Assurance Engineer Design Control

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Written by AI from the job title and company, not by Precision Medicine Group, so some details may not match this job. The employer's own page has the real description.

Job Overview

The Quality Assurance Engineer Design Control at Precision Medicine Group plays a pivotal role in ensuring that the design and development processes of medical products comply with regulatory requirements and internal quality standards. This position involves the application of quality engineering principles throughout the product lifecycle, from design input through to design verification and validation. The ideal candidate will work collaboratively with cross-functional teams to establish, implement, and maintain a robust quality management system, ensuring that all products meet customer and regulatory expectations for safety and effectiveness.

Job Responsibilities

• Develop and maintain design control documentation, including design history files (DHFs) and design control plans.
• Collaborate with R&D to establish and implement design inputs and outputs that meet regulatory and customer requirements.
• Lead risk management activities and ensure compliance with ISO 14971 and other applicable standards.
• Conduct design verification and validation activities through test planning, execution, and reporting.
• Perform audits and assessments to ensure adherence to quality systems and procedures.
• Provide training and guidance on design control processes to cross-functional teams.
• Support regulatory submissions and inspections through documentation and audit preparation.
• Investigate and resolve quality issues related to design controls, implementing corrective and preventive actions as needed.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field; a Master's degree is a plus.
• A minimum of 3 years of experience in Quality Assurance within the medical device or pharmaceutical industry.
• Strong knowledge of FDA regulations, ISO standards, and QSR requirements.
• Experience with risk management principles and tools.
• Proficiency in quality management systems and methodologies.
• Excellent analytical, problem-solving, and organizational skills.
• Effective verbal and written communication skills.

Technologies & Tools

The Quality Assurance Engineer Design Control will utilize a range of technologies and tools essential for quality management and design control. This includes software for document management systems (DMS), project management tools like JIRA or Trello, and statistical analysis software such as Minitab. Familiarity with Electronic Lab Notebooks (ELNs) and tools for regulatory compliance, such as MasterControl or Trackwise, will also be advantageous.

Ideal Candidates

The ideal candidate for the Quality Assurance Engineer Design Control role at Precision Medicine Group should possess a detail-oriented mindset with exceptional analytical abilities. They should be proactive and self-motivated, demonstrating strong leadership skills to foster collaboration among diverse teams. Excellent communication skills are essential for effectively articulating quality goals and requirements. A genuine passion for quality and patient safety, coupled with a commitment to continuous improvement and regulatory excellence, will set candidates apart in this role.