Quality Assurance Engineer Design Control

This job was posted over 30 days ago, so it has most likely closed. See newer jobs like it.

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.

Job Overview

The Quality Assurance Engineer Design Control at Precision For Medicine will play a pivotal role in ensuring that products meet rigorous quality standards throughout the design and development process. This position focuses on compliance with regulatory requirements, implementation of quality management systems, and continuous improvement initiatives. The successful candidate will collaborate with cross-functional teams to identify quality risks and establish effective mitigation strategies. This role is essential in contributing to the overall mission of delivering high-quality medical products while fostering a culture of quality excellence within the organization.

Job Responsibilities

• Develop and maintain design control documentation in compliance with applicable regulations and internal procedures.
• Perform risk management activities including Failure Modes and Effects Analysis (FMEA) and Design Reviews.
• Conduct regular audits of design control processes and systems to identify areas for improvement.
• Facilitate the creation and revision of standard operating procedures (SOPs) related to quality assurance.
• Collaborate with R&D and manufacturing teams to ensure adherence to quality standards at all stages of product development.
• Assist in the preparation and execution of validation and verification activities.
• Investigate quality issues, conduct root cause analysis, and implement corrective actions as necessary.
• Prepare and present quality reports to management and stakeholders to communicate compliance status and improvement opportunities.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related discipline.
• A minimum of 3 years of experience in quality assurance within a regulated industry, preferably in medical devices or diagnostics.
• In-depth knowledge of ISO 13485 and FDA regulations as they pertain to design control.
• Experience with quality management systems and methodologies such as CAPA, CAPA Management, and Internal Audits.
• Strong analytical skills and attention to detail.
• Excellent communication skills, both written and verbal.
• Proficient in Microsoft Office Suite and familiarity with statistical analysis software.

Technologies & Tools

The Quality Assurance Engineer Design Control will utilize a variety of technologies and tools to support quality assurance efforts. This includes quality management software programs for tracking compliance, documentation management tools for maintaining design control records, and statistical software for data analysis. Familiarity with electronic lab notebooks (ELN) and risk management tools will also be essential for success in this role, along with standard office software applications for reporting and communication.

Ideal Candidates

Ideal candidates for the Quality Assurance Engineer Design Control position are detail-oriented professionals who possess a critical thinking mindset and thrive in a collaborative environment. They are proactive in identifying potential quality issues and adept at implementing effective solutions. A strong commitment to regulatory compliance and a continuous improvement ethos are vital traits. Additionally, they should demonstrate exceptional interpersonal skills to engage with various teams effectively, and a passion for the quality assurance field that drives them to uphold the highest standards in product development.