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Quality Assurance Product Engineer

2 months ago

Alabama, United States Agilent Full time

Job Overview

The Quality Assurance Product Engineer is dedicated to delivering exceptional quality experiences for our clients and patients. This role encompasses the management and enhancement of quality engineering processes throughout the product lifecycle, including design transfer and risk management updates for relevant product lines.

Key responsibilities include leading product quality investigations arising from customer feedback and facilitating root cause analyses related to product and manufacturing challenges. This involves the review and alignment of Corrective Action/Preventive Action (CAPA) plans in accordance with corporate standards and guidelines across the organization.

The role requires a thorough understanding of intricate processes, challenges, and compliance issues, articulating them clearly to ensure effective CAPAs and comprehensive root cause analyses.

Collaboration with various quality functions and post-market surveillance experts is essential to ensure compliance and support Research & Development in implementing minor design modifications and updates to the product portfolio.

Core Responsibilities:

Lead investigations into product quality issues stemming from customer complaints and support root cause analysis for product and manufacturing challenges. Review and align CAPA plans in line with corporate policies and guidelines. Analyze complex processes and compliance issues, articulating them clearly for audit and inspection purposes. Work closely with other quality functions and post-market surveillance teams. Assist R&D in maintaining compliance during minor design changes and product updates. Utilize advanced Quality Assurance methodologies and scientific principles in daily tasks. Apply relevant regulations, standards, and industry best practices to all assignments. Plan and execute projects with significant technical responsibility and complexity. Serve as a subject matter expert in routine quality assurance and scientific matters. Drive strategic quality assurance initiatives across the organization. Collaborate with quality partners to identify necessary skills and competencies for executing strategic objectives. Participate in quality systems initiatives that impact business improvement and lifecycle management. Perform additional duties as assigned.

Qualifications:

Bachelor's or Master's Degree in engineering, science, or a related technical field is preferred. A minimum of 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 root cause investigations and assessing the effectiveness of corrective actions. Proficiency in applying established tools and methodologies (e.g., Six Sigma, Lean) for process improvements. Ability to review and approve complex CAPA issues to ensure successful audit outcomes. A detail-oriented and proactive team player, capable of cross-functional collaboration.

What We Offer:

A dynamic and collaborative environment with approximately 40 skilled colleagues in the Quality Assurance department. Opportunities to make a significant impact and develop skills within a leading company focused on innovative solutions for pathology labs worldwide. A role in a growth-oriented and inclusive environment, fostering integrity, collaboration, and trust. Comprehensive global benefits, including performance bonuses and stock purchase plans.

Pay Range:

The salary range for this position may vary based on work location and individual qualifications.

Remote Work Option: Yes

Travel Requirements: Occasional

Job Function: Quality/Regulatory