Principal Quality Engineer

Overview

Serves as a senior technical member of the global Quality Assurance team. Supports both global and corporate leadership with strategic guidance of quality system statistics and data analytics and risk management.

The Principal Quality Engineer works independently with limited oversight and manages complex / difficult technical projects or processes that have a major impact on company / departmental results.

The Principal Quality Engineer acts as a mentor and leader in the department and reviews work outputs of less experienced engineers / contractors in the department, in order to achieve departmental goals.

Responsibilities

• Lead and influence discussions within team / department and with other functional personnel (Production Engineering, Product Management, Regulatory, Clinical, Quality Engineering, Quality Assurance, Operations, sourced vendors, and physicians) as necessary to progress projects / tasks.
• Efficiently manages multiple project / task timelines, resources and responsibilities to achieve team, departmental, and company goals.
• Identify and escalate problems / obstacles to appropriate level of management and implement possible solutions as necessary.

Works with other team members to provide problem-solving guidance. Utilizes broad and deep experience strategically to inform project / task decisions.

• Presents project / task status updates clearly to team members and team lead / manager. May also present to global functional leaders / executives as necessary.
• Provide guidance and assistance to engineers and other technical employees / co-ops / interns / contractors. May review and approve outputs as necessary.
• Leads long-term planning efforts to improve monitoring, metrics, and analytical models to support QS and product continual improvement.
• Provides strategic guidance for corporate and global quality system statistics, data analytics, and risk management.
• Demonstrates deep quality system, data and risk knowledge including process and regulatory details. Recognized as company expert in these areas.
• Projects may include system or program level activities, providing overall guidance and leadership and delegating tasks as appropriate.

Projects may affect multiple departments and / or global manufacturing entities.

• Follow Risk Management procedures and comply with requirements of ISO 14971 as applicable.
• Must maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Qualifications

• Bachelors degree in Engineering, Life Science or similar field. Master's or PhD preferred.
• Minimum 10 years experience working with quality management systems, engineering principles and statistics.
• Minimum 10 years experience in a regulated industry, preferably in a medical manufacturing environment.
• Expertise with statistical practices as it relates to sample sizes, confidence intervals, capability, assessing risk and demonstrated problem solving experience.
• Experience in communication and working with a wide variety of associates.
• Experience working independently and directing others toward a common goal.
• Proficiency in the Microsoft Office suite of products (Word, Excel, PowerPoint, and Outlook), JBase, Engineering Server, Business Objects, and statistical software.
• Strong organizational skills.
• Critical thinking and attention to detail required.
• Excellent verbal communication skills and technical writing.

Physical Requirements :

• Works under general office environmental conditions, including time in manufacturing environment and biohazard lab
• Sitting for extended periods, utilizes close visual acuity for working with computers, equipment, etc.
• Occasional travel may be required
29 days ago