Luis Donis Email & Phone Number

Milford, Ma, Us

Shrewsbury, Massachusetts, United States

• Spearheaded QA Engineering and Analyst teams, ensuring comprehensive oversight of manufacturing quality activities. Stablished monthly reports that reflect in real time the current state of the business from the quality and compliance perspective. • Directed defect mitigation efforts, maintaining strict adherence to quality standards, and significantly reducing defect rates. Reducing defects in 30%, DPPM in 15%, Aging records in 25% CAPA Closure in 100%• Implemented corrective actions to ensure seamless regulatory compliance and internal policy adherence. Reducing audit findings in 10%

United States

• Provided critical support to manufacturing operations, new product launches, and custom projects. Supporting business revenues growth from $70 MM to 85 MM• Led multiple control boards, overseeing deviation management, and ensuring effective change control processes. Reducing the overdue records below the threshold of 10%• Ensured the reliability and compliance of product designs through meticulous design transfers and production ramp-ups.

Massachusetts, United States

• Provided critical support to manufacturing operations, new product launches, and custom projects. Supporting business revenues growth from $70 MM to 85 MM• Led multiple control boards, overseeing deviation management, and ensuring effective change control processes. Reducing the overdue records below the threshold of 10%• Ensured the reliability and compliance of product designs through meticulous design transfers and production ramp-ups.

14 Walkup Drive Westoborough Ma.

Westborough, Massachusetts

• Initiated cleanroom LEAN initiatives, substantially enhancing efficiency and output across various manufacturing lines in 40%• Instrumental in boosting production line output by 80% through active participation in AKTA production line AWO.• Achieved a consistent 25% quarterly improvement in cleanroom Class VII liquidation output, showcasing a commitment to continuous improvement.

Westborough, Massachusetts

• Provided strategic leadership and technical expertise in developing and enhancing Cleanroom quality systems. Implemented projects that reduce the rework rate in 40%• Oversaw the Non-Conforming Material (NCM) handling process and chaired the Material Review Board (MRB). Decreasing the inventory value in 90%• Conducted thorough root cause investigations and collaborated with Supplier Quality to resolve defects effectively. Improving the investigation response in 75% and decreasing the external defects rate in 35%.

Westborough Ma

My role provides leadership and support for the development and direction of production teams. Support the implementation of actions to improve product, productivity and process quality. Also supporting the culture change incorporating LEAN principles in order to simplify and accomplish the organization goals.My responsibilities are monitoring and improving productivity, Developing and create training plans,Leading EHS and QMS compliance, Driving LEAN manufacturing implementation, Identify and report manufacturing and Quality and EHS concerns, Have knowledge and understanding of production process Work Instructions to ensure that our product complies with the highest standards of our costumers.