Quality Engineer 2 - R&D Operations

Merck•Bedford, MA

About The Position

MilliporeSigma is seeking a Quality Engineer to support the Quality and Site Operations team in Bedford, MA by maintaining the R&D Quality Management System in alignment with ISO 9001:2015. The role leads quality audits to evaluate compliance, surface risk, and identify improvement opportunities to strengthen site and organizational performance. In addition to audit leadership, this role flexes to support site operations activities and site events as needed, partnering cross-functionally to help the site execute priorities and drive continuous improvement.

Requirements

Bachelor’s degree in a Science or Engineering field
3+ years of Quality Engineering experience, including at least 2 years of experience as an Auditor
2+ years of experience with CAPA management, deviations, and quality systems
2+ years of experience with electronic quality systems such as TrackWise

Nice To Haves

Excellent communication skills with the ability to influence and collaborate across all levels
Detail-oriented, highly organized, and strong in problem-solving and follow-through
Product development experience
ASQ CQA certification
Collaborative and motivated team player, always looking to share and advance best practice
Proven hands-on experience auditing to ISO 9001:2015 standards
Proven experience leading audits, including planning, execution, reporting, and follow-up
Ability to write clear, evidence-based audit reports and communicate findings with professionalism and firmness
Ability to identify systemic issues, assess risk, and link observations to process and QMS controls
Experience with electronic QMS tools (e.g., document control, training, deviations/nonconformance, CAPA)
Comfortable working independently and prioritizing multiple quality tasks and follow-ups
Comfortable shifting between auditing work and broader site support needs in a dynamic environment

Responsibilities

Implement and maintain the ISO 9001:2015 QMS for the R&D environment.
Lead annual internal audits, including planning, execution, and follow-up.
Prepare detailed audit reports with evidence, risk-based findings, and actionable recommendations.
Manage audit findings in Veeva; review deviations and CAPAs to ensure timely closure and effectiveness.
Develop, review, and maintain site-relevant SOPs and supporting documents.
Coach R&D stakeholders on audit readiness and documentation standards.
Deliver training and audit preparation sessions to strengthen readiness and consistency.
Support cross-functional initiatives and site operational needs, including coordinating and executing site events and activities as needed.
Drive continuous improvement by identifying opportunities to simplify, strengthen controls, and improve operational effectiveness.
Support site operations initiatives, including sustainability, digitalization, and automation projects, by coordinating quality input, documentation, and cross-functional follow-through.
Perform other related duties as needed in support of site and business priorities.