Quality Assurance Engineer Design Control

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

Overview

The Quality Assurance Engineer - Design Control at Precision For Medicine is pivotal in ensuring that all design processes meet the highest quality standards and regulatory requirements. This role involves collaborating with cross-functional teams to facilitate the design and development of medical devices, providing oversight in compliance with FDA regulations and ISO standards. The engineer will be responsible for developing, implementing, and maintaining quality assurance processes that enhance product reliability, effectiveness, and patient safety.

Job Responsibilities

• Develop and maintain design control documentation in accordance with FDA and ISO standards.
• Conduct reviews of design outputs and verify compliance with design inputs.
• Facilitate risk management activities including FMEA and design validation/verification.
• Collaborate with R&D, regulatory, and manufacturing teams to ensure quality throughout the product lifecycle.
• Support internal and external audits by providing necessary documentation and process insights.
• Develop and implement quality assurance plans and process improvement initiatives.
• Provide training to team members on quality assurance processes, procedures, and tools.
• Monitor and report on key quality metrics and propose corrective actions for non-conformities.

Qualifications

• Bachelor's degree in Engineering, Quality Assurance, or a related field.
• Minimum of 3 years of experience in quality assurance, specifically in design control for medical devices.
• Strong knowledge of FDA regulations, ISO 13485, and other relevant quality standards.
• Proficiency in risk management methodologies and quality management systems.
• Excellent analytical skills and attention to detail.
• Strong communication and interpersonal skills for cross-functional collaboration.
• Ability to work independently and manage multiple projects effectively.

Technologies & Tools

The Quality Assurance Engineer - Design Control will be working with various technologies and tools, including but not limited to, Quality Management Systems (QMS), risk management software (such as RiskWatch or ISO 14971-compatible tools), Statistical Process Control (SPC) software, and design documentation tools (like MasterControl or Arena PLM). Familiarity with electronic laboratory notebooks (ELN) and Computerized Maintenance Management Systems (CMMS) is also beneficial.

Ideal Candidates

The ideal candidate for the Quality Assurance Engineer - Design Control position possesses a combination of technical expertise and strong soft skills. They are detail-oriented and proactive problem solvers who thrive in a team-oriented environment. A commitment to continuous learning and improvement is essential, coupled with the ability to work under pressure and meet tight deadlines. Strong ethical judgment and integrity in handling sensitive quality data are also crucial characteristics that define the best fit for this role.