Sr. Quality Assurance Associate

The businesses of Merck KGaA, Darmstadt, Germany•Sheboygan Falls, WI

2d•$26 - $44•Hybrid

About The Position

The Sr. Quality Assurance Associate at MilliporeSigma in Sheboygan Falls, WI, will be a member of the Electronics Thin Film Support team supporting quality systems, and ensuring their alignment with business goals, premier customer expectations and requirements, as well as global business unit best practices. The Associate will establish strong collaborative relationships with all departments within the organization and will deliver on quality and regulatory commitments, working autonomously to effectively manage delivery of results within targeted deadlines. Responsibilities include the following: Coordinate and lead cross-functional meetings to implement and manage critical quality initiatives Represent the company in customer meetings to ensure ongoing compliance with and satisfaction of customer requirements Develop and refine Quality System components to exceed key customer expectations Manage document control processes, including conducting annual product reviews as needed Contribute to Deviation and Material Review Board activities Lead and facilitate investigations into customer complaints and corrective actions Manage and support change control processes and deliverables Conduct, participate in, and lead internal quality audits Create and review documentation to guarantee adherence to company and customer quality standards Deliver quality awareness training to site personnel Generate and present quality reports for local management and customers Oversee the calibration program, including managing out-of-calibration events within the quality system Contribute to the development, maintenance, and enhancement of quality systems, ensuring alignment with business objectives, customer requirements, and global best practices Weekly schedule, days/hours: Monday – Friday, 7:00 AM – 3:30 PM. This position can be a hybrid role, working on-site as needed (typically 2-3 days per week) and possibly 40 hours per week as projects necessitate

Requirements

High school diploma or GED and 3+ years of experience in a quality role
Bachelor’s degree in science, engineering, or business/mathematics with course work completed in chemistry or other science discipline and 1+ year of experience in a quality role

Nice To Haves

3+ years of experience in a quality role
Excellent communication skills
Understanding of Quality System Regulations, ISO Quality Systems and other FDA Regulations
Strong computer skills, and knowledge of ERP systems
Excellent problem-solving skills with the ability to implement relevant solutions to problems or situational changes
Good time management skills
Ability to increase efficiencies in the continuous improvement of the quality management system
Ability to work independently and in a fast-paced, team environment

Responsibilities

Coordinate and lead cross-functional meetings to implement and manage critical quality initiatives
Represent the company in customer meetings to ensure ongoing compliance with and satisfaction of customer requirements
Develop and refine Quality System components to exceed key customer expectations
Manage document control processes, including conducting annual product reviews as needed
Contribute to Deviation and Material Review Board activities
Lead and facilitate investigations into customer complaints and corrective actions
Manage and support change control processes and deliverables
Conduct, participate in, and lead internal quality audits
Create and review documentation to guarantee adherence to company and customer quality standards
Deliver quality awareness training to site personnel
Generate and present quality reports for local management and customers
Oversee the calibration program, including managing out-of-calibration events within the quality system
Contribute to the development, maintenance, and enhancement of quality systems, ensuring alignment with business objectives, customer requirements, and global best practices