Quality Assurance Engineer

2 weeks ago

Alabama, United States Agilent Full time

Position Overview

The Quality Assurance Engineer is committed to delivering exceptional quality experiences for our clients and patients. This role encompasses the responsibility of leading and facilitating quality engineering initiatives related to lifecycle management, including design transfer and risk management updates for the associated product lines.

Daily responsibilities include conducting product quality investigations arising from customer feedback and spearheading root cause analyses related to product and manufacturing challenges. This involves reviewing and aligning Corrective Action and Preventive Action (CAPA) processes in accordance with corporate protocols and guidelines across the organization. Additionally, the role requires a clear articulation of complex processes, challenges, and quality/compliance matters to ensure effective CAPAs and comprehensive root cause analyses.

Collaboration with various quality functions and post-market surveillance experts is essential in this position.

Furthermore, the Quality Assurance Engineer will assist Research and Development in maintaining compliance during minor design modifications and updates to our product offerings.

Key Responsibilities:

Lead product quality investigations resulting from customer complaints and facilitate root cause analyses related to product and manufacturing challenges. Review and align CAPAs in accordance with corporate standards and guidelines across the organization. Comprehend intricate processes, challenges, and quality/compliance issues, and convey them in a clear and concise manner suitable for audit and inspection scenarios. Collaborate closely with other quality functions and post-market surveillance specialists within the team. Support R&D in ensuring compliance during minor design modifications and updates to our product offerings. Implement advanced Quality Assurance and Scientific Method techniques and principles in daily tasks and activities. Apply relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plan and execute projects and activities with moderate to high technical responsibility, complexity, and strategic input. Serve as a subject matter expert in routine quality assurance and scientific matters as applicable. Develop and drive key strategic quality assurance and scientific initiatives throughout the organization. Collaborate with other quality partners to identify necessary quality assurance skills and competencies to execute strategic visions or plans. Participate in quality systems initiatives as a primary or additional assignment, potentially impacting business improvement, quality systems, and lifecycle management. Perform other duties as assigned.

Qualifications:

Bachelor's or Master's Degree in engineering, science, or a related technical field is preferred. 4+ years of relevant experience in a regulated industry (medical device, biopharmaceutical, or pharmaceutical) is preferred. Familiarity with ISO 13485, FDA CFR 21 Part 820, and ISO 14971 is essential. Experience in leading and/or contributing to root cause investigations using various problem-solving techniques and tools, as well as assessing the effectiveness of corrective actions. Proficiency in driving root cause analysis and CAPA investigations. Demonstrated expertise in applying established tools and methods (e.g., Six Sigma, Lean) to identify and implement new process introductions, as well as process and business improvements. Ability to review and approve complex CAPA issues to ensure successful audit outcomes. On a personal level, you are detail-oriented and a proactive team player capable of working cross-functionally with individuals at all levels of the organization.

We Offer:

A dynamic and collaborative environment with approximately 40 skilled colleagues in the QA department providing support within development, manufacturing, and sustain activities. An excellent opportunity to make a significant impact and enhance your skills in a world-class organization dedicated to developing innovative solutions for pathology labs globally to improve cancer diagnostics. A role among passionate colleagues in a growth-oriented and inclusive environment, fostering a caring and fast-paced atmosphere built on integrity, sharing, and trust. Core global benefits for all staff, including a performance-based bonus and stock purchase plan.

Pay Range:

The salary range for this position may differ based on your actual work location.

Remote Work Option: Yes

Travel Requirements: Occasional

Schedule: Full time

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory

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