Quality Engineer 2 - R&D Operations

Work Location: Bedford, Massachusetts
Shift:
Department: LS-PS-RVQ Quality & Site Operations
Recruiter:Beverly Dellisola

This information is for internals only. Please do not share outside of the organization.

Your Role:

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.

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.

Who You Are:

Minimum Qualifications:

• 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

Preferred Qualifications:

• 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

Pay Range for this position: $83,200 - $124,800

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here.

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.