Principal Quality Engineer - Rochester, United States - Endo

Description

Why Endo?

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We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.

The Principal Quality Engineering Independently supports the most complex projects, collaborating with other quality, engineering, and manufacturing operations functions to ensure the quality aspects of validation and qualification activities, performing various types of analysis and generating and reviewing internal investigations, CAPAs, and change controls. Leads multi-functional teams in special, highly sensitive, and/or cross-site projects. Leads investigations, corrective actions, continuous improvement projects, and process capability improvements. Coaches personnel across departments in quality processes and mentors more junior Quality Engineers in the use of decision-making tools.

Validation & Qualification

• Independently supporting the most complex projects, collaborates with other quality, engineering, and manufacturing operations functions ensure all quality aspects of validation and qualification activities at the site including process validation, facility qualification, equipment validation (URS), IQ, OQ and PQ
• Reviews and may approve the generation and maintenance of validation/qualification protocols and Validation Master Plans

40%

Analysis

• Demonstrates break-through thinking to solve complex problems
• Leads multi-functional teams in special, highly sensitive, and/or cross-site projects
• Mentors more junior Quality Engineers in the use of decision-making tools
• Performs statistical analysis for the identification of trends
• Collaborates with other departments to implement improvements

30%

Compliance

• Coaches personnel across departments in quality processes
• Provides subject matter expertise to support other departments (e.g. change controls, SOPs, CAPAs, investigation etc.) to ensure compliance with cGMPs
• Reviews and approves engineering Change Controls
• Collaborates with other departments to ensure quality standards are in place
• Leads investigations, corrective actions, continuous improvement projects, and process capability improvements (FMEA, root cause analysis, process mapping, Six Sigma, SPC, DOE, etc.)
• Authors/revises department SOPs that reflect current practices and are in compliance with FDA and other regulatory requirements and guidances

25%

Metrics

• Presents data at Management Reviews

5%

Qualifications

Education & Experience

• BS in Engineering, Science, or equivalent plus a minimum of 10+ years of relevant experience. Advanced degree a plus

Knowledge

• Knowledge of statistics, failure modes and effects analysis, root cause analysis, process mapping, statistical process control, design of experiments, and other related engineering tools

Skills & Abilities

• Ability to lead teams
• Ability to coach personnel across departments and to mentor other Quality Engineers
• Ability to display and analyze data in a logical manner
• Good communication skills, including reading and understanding technical instructions
• Good attention to detail
• Solid organizational skills
• Ability to take initiative, set priorities and follow through on assignments

Physical Requirements

• Ability to stand for up to 8 hours
• Ability to wear personal protective equipment, including respirators, gloves, etc.
• Manual dexterity
• Ability to lift and carry 15 lbs.