Senior Supplier Quality Engineer

The businesses of Merck KGaA, Darmstadt, Germany•Lenexa, KS

About The Position

In this role, you will be pivotal in upholding the highest quality standards throughout the product life cycle. Your responsibilities will encompass evolving a meticulously organized approach to product releases, labeling approvals, and ensuring process consistency. This will involve rigorous reviews of executed batch records, raw material documentation, and product release records, which are essential for maintaining compliance with industry standards. As a key contributor to collaboration with Quality Control, you will engage in batch release and testing processes, addressing out-of-specification (OOS) and out-of-trend (OOT) scenarios. With a focus on fostering strong internal relationships, you will drive excellence within the External Manufacturing Quality group while supporting MilliporeSigma's quality systems, including participation in audits and the implementation of corporate policies. Your role will not only be to ensure compliance and quality but also about innovating customer service approaches and problem-solving methodologies to meet both regulatory and customer expectations.

Requirements

Bachelor’s Degree or higher in science related majors
5+ years of quality related experience in engineering, biotechnology, and/or life sciences
Excellent communication skills with business-fluent English
Strong understanding in ISO 9001:2015
Excellent oral and written communication skills, ideally with experience in Quality communications
Capable of working across a variety of systems, ERPs, electronic platforms, and Quality Management Systems
Self-directed and self-motivated with strong organizational skills and ability to continually prioritize projects and tasks with varying requirements and deadlines
A desire and ability to connect with people at all levels of the organization and external partners, building trust and rapport while collaborating

Nice To Haves

Demonstrated Life Science, Chemicals or Healthcare industry knowledge
Knowledge of manufacturing processes and product life cycles
Working knowledge of SAP; Mango, TrackWise, Falcon are a plus
Mindset and skills for continuous improvement initiatives
Experience managing chemical and biological suppliers is a plus.
Experience with new product introduction and buy/resell processes is a plus.
Experience in cross-functional projects

Responsibilities

Write/revise and review Operating Procedures and other QA controlled documents under an ISO 9001 quality system. Become point of contact with QC for serum specific topics.
Support MilliporeSigma quality systems, e.g., corporate, internal & external audits and corporate policy implementation(s).
Participate in deviation, corrective and preventative actions, and change control.
Become a role model for customer service and forward-thinking approaches to problem solving.
Opportunity to track, trend, and action complaints depending on experience.
Independently manage and engage in day-to-day interaction with suppliers to ensure on-time delivery of goods and solving quality/production related issues.
Evaluation, monitoring, and quality improvement of external suppliers.
Cultivate and maintain positive, collaborative relationships with key suppliers based on trust, open communication, and mutual respect.
Work closely with cross-functional teams including Supply Chain, R&D, Procurement, and Trade Compliance to ensure product delivery and quality standards, customer, and regulatory requirements.
Develop qualification and validation documentation to support changes to existing products and/or processes.
Support NPI and Project teams to ensure procedures are available, accurate, and adhered to appropriately.
Be amenable to various project assignments
Ensure each NPI project aligns to the LS and Site level procedures in place including the needed documentation for each step.