Senior Manufacturing Quality Engineer

Bausch & Lomb GmbH; Greenville (SC); On-site; USD 85,000 - 120,000; Full time

Job summary

Bausch + Lomb is hiring a Quality Engineer in Greenville, SC, focusing on ensuring compliant manufacturing and distribution processes across the product life cycle. You will participate in product design, manufacturing support, and post-launch maintenance, applying quality principles and regulatory guidelines.

Responsibilities include leading investigations, using Lean/Six Sigma tools, and driving corrective actions, with strong emphasis on data-driven decision making and risk mitigation.

Qualifications

• BA/BS in life sciences or engineering; strong knowledge of quality systems.
• 5+ years in quality; experience in medical devices or pharmaceutical manufacturing preferred.
• Experience leading investigations and applying 21 CFR and ISO standards.

Responsibilities

• Ensure new products integrate into quality system and processes.
• Lead continual improvement plans with manufacturing and engineering teams.
• Conduct investigations, root cause analysis, and corrective actions.
• Apply Lean/Six Sigma tools for process control improvements.
• Present performance indicators to management and operators.
• Guide qualification/validation criteria with engineering teams.

Skills

Quality engineering

Root cause analysis

Statistical analysis

Manufacturing support

Education

BA/BS in life sciences or engineering

Tools

Quality tools

Job description

Bausch + Lomb (NYSE/TSX: BLCO) is a leading global eye health company dedicated to protecting and enhancing the gift of sight for millions of people around the world—from the moment of birth through every phase of life. Our mission is simple, yet powerful: helping you see better, to live better.

Our comprehensive portfolio of over 400 products is fully integrated and built to serve our customers across the full spectrum of their eye health needs throughout their lives. Our iconic brand is built on the deep trust and loyalty of our customers established over our 170-year history. We have a significant global research, development, manufacturing and commercial footprint of approximately 13,000 employees and a presence in approximately 100 countries, extending our reach to billions of potential customers across the globe. We have long been associated with many of the most significant advances in eye health, and we believe we are well positioned to continue leading the advancement of eye health in the future.

Purpose of Job

The role of Quality Engineer is integral to the on-going compliance of the manufacturing and distribution processes. The Quality Engineer is involved in all stages of the product life cycle — Product design, manufacturing support, and post-launch maintenance.

Key Activities

• Ensures that new products are properly integrated into the existing quality system.
• Leads efforts in conjunction with manufacturing and engineering to develop plans for continual improvement of product and process quality.
• Ensures that decisions are made based on sound Quality principles and regulatory guidelines.
• Supports/leads investigations and corrective action efforts.
• Promotes use of statistical analysis for determination of improvements, and provides analyses to support risk mitigation.
• Evaluates complaint trends to drive improvements, assisting in their investigation as necessary.
• Independently leads failure investigations, using root cause analysis tools, and proposing/implementing systemic corrective actions.
• Uses Lean/six sigma tools to identify areas of improvement, specifically related to process controls by using relevant statistical tools to analyze data for proactive improvements.
• Provides routine analysis of performance indicators. Presents this information to management, supervisors, and manufacturing operators.
• Guides engineering/manufacturing personnel in establishment of appropriate qualification, validation criteria.

Qualifications

• Four-year college degree (BA/BS) in fields such as life, physical sciences, or engineering.
• Preferred: Experience in aseptic manufacturing or parental (parenteral) product manufacturing in a cGMP environment.
• 5+ years Quality experience, 3 years minimum in medical devices or pharmaceutical manufacturing. Strong verbal and written communication skills, ability to manage multiple priorities. Working knowledge of 21CFR820, 21CFR210/211, ISO 13485, ISO 9001, Quality tools, and problem-solving tools, statistical analysis.
• Experience in leading, conducting and writing investigations.

This position may be available in the following location: Greenville, SC

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.