Quality Engineer - Katalyst Healthcares & Life Sciences
Leominster, MA 01453
About the Job
Responsibilities:
- Expertise in quality management systems for machine shop and metal precision partes development.
- Develop IQ, OQ, PQ protocols/reports, Develop TMVs protocol/report, Develop validation methodology.
- Perform Metrology and GR&R and Capability Analysis and Reports ISO 13485: Comprehensive knowledge and hands-on experience with ISO 13485 standards and implementation.
- Expertise in developing and maintaining control plans to ensure product quality and consistency.
- APQP (Advanced Product Quality Planning): Proficiency in APQP processes, ensuring that product development meets all quality and performance requirements.
- Solid understanding and practical application of metrology principles and techniques in a manufacturing environment. They do not need to know how to program a CMM however, they need to be able to understand the data.
- In-depth experience in supporting and operating in a quality system.
- Discipline in Problem Solving: Demonstrated ability to lead disciplined problem-solving initiatives, using structured methodologies such as Six Sigma, Root Cause.
- Skilled in identifying, assessing, and mitigating risks associated with product quality and regulatory compliance.
- Proven ability to manage supplier quality performance, conduct audits, and implement improvement plans.
- Proficient in using statistical tools and techniques for data analysis, process control, and quality improvement.
- Strong project management skills with the ability to manage multiple projects simultaneously, ensuring timely and successful completion.
- Ability to train and develop quality team members, fostering a culture of continuous improvement.
- Expertise in conducting thorough root cause analysis to identify and resolve quality issues.
Source : Katalyst Healthcares & Life Sciences
