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.
- Certifications preferred: CQA, CQE, CQM.
- 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
Our Benefit Programs: Employee Benefits: Bausch + Lomb
