Quality Assurance Specialist

Millipore Corporation; Sheboygan Falls (WI); On-site; USD 69,000 - 116,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Other perquisites

Job summary

MilliporeSigma is seeking a Quality Assurance Specialist to strengthen quality systems across global operations. You will focus on supplier quality management and general QMS improvements to align with business goals and customer requirements.

The role emphasizes audits, data analysis, and documentation to ensure regulatory compliance and product quality in healthcare, life science, and electronics domains.

Qualifications

• Bachelor’s degree in life sciences or engineering with quality experience.
• FDA/Regulatory knowledge and auditing experience preferred.
• Experience with quality systems and documentation control.

Responsibilities

• Develop and maintain quality systems aligned with business goals.
• Lead supplier quality management activities and audits.
• Facilitate quality system initiatives and data analysis.
• Ensure compliance with regulatory standards as applicable.

Skills

QMS knowledge

Audits experience

Data analysis

Documentation

Communication skills

Regulatory familiarity

Education

Bachelor's degree in biology/chemistry/engineering

High School Diploma + 3+ years quality or 5+ years PM/production

Tools

SAP

TrackWise

Document Control Systems

Microsoft Office

Job description

Work Your Magic with us! Start your next chapter and join MilliporeSigma. Ready to explore, break barriers, and discover more? We know you've got big plans - so do we! Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimaginable with us.

This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

Your Role

The Quality Assurance Specialist will facilitate and support the development, maintenance, and improvement of quality systems, to ensure their alignment with business goals, customer expectations, and requirements for global business unit best practices. This position will have a strong focus in Supplier Quality Management and general Quality Management System requirements and improvements.

Responsibilities

• Quality system development and maintenance activities
• Support supplier quality management activities and programs
• Lead and facilitate supplier development activities including audits
• Lead, facilitate and support various quality system initiatives

Minimum Qualifications

• Bachelor's degree in biology, chemistry, mechanical engineering, chemical engineering or other life science discipline or engineering discipline OR High School Diploma or GED and 3+ years of experience in a quality role or 5+ years in a production, or project management role

Preferred Qualifications

• 3+ years of knowledge and experience in Quality Management Systems, ISO Quality Standards, and other regulatory standards as appropriate. (FDA, VDA, DOT, IATA, DEA, etc.)
• 1+ year of knowledge and experience in 21CFR117
• Experience with hosting and performing internal and external audits
• Experience with understanding data analysis, presentation, and experimental design
• Experience understanding current processing requirements for food, drug, industrial, and biologic types of products
• Strong oral and written communication skills
• Life science, Chemical, Food Industry, or Healthcare industry experience
• Experience with SAP, TrackWise, Document Control Systems, and Microsoft Office
• Experience in preparing and reviewing documentation to ensure compliance with company or customer quality requirements

Pay Range for this position

$69,100 - $115,600/yr 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

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites

What we offer

We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!