Show All Results
Quality Engineer II
A career with MilliporeSigma is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
As a Quality Engineer at MilliporeSigma in our Danvers, MA, production site, you play a key role in the success of the Quality and Manufacturing organizations. Key responsibilities include:
- Project Leader for process improvement projects
- Utilize root cause analysis tools to complete product and process related investigations
- Lead and support risk assessments utilizing FMEA
- Review and improve standard operating procedures and other production documentation
- Support customer-facing improvement projects that incorporate evolving customer and industry requirements
- Conduct internal GMP and ISO audits
- Support deviation resolution in production and corrective action implementation
- Assures products are manufactured in compliance with regulatory requirements and manufacturing plans are monitored for compliance to ISO, GMP, and MilliporeSigma standards
- Monitor and trend process performance and drive continuous improvement
- Lead projects with cross functional teams to improve in-process quality, reduce customer complaints, and increase production efficiency
Weekday Shift: Monday-Friday
Who You Are:
- Bachelor’s Degree in Engineering, Biology, Chemistry, or related field
- 2+ years of experience in Biotechnology, Pharmaceutical, Medical Device, or Life Science industries
- Lean Six Sigma and/or root cause analysis training
- Experience leading risk assessments using tools such as FMEA
- Experience with Quality Systems (e.g. Deviation, CAPA, Change Control, Documentation Management)
- Experience conducting internal/customer/supplier audits
- Demonstrated ability to write and execute test protocols and reports
- CQA or CQE
- Strong problem-solving and project management skills
- Proven track record of working collaboratively and communicating successfully in a cross-functional and multi-cultural environment
- Demonstrate strong quality knowledge: GMP/GDP, ISO standards
- Intermediate computer skills and proficiency in Microsoft Office
- Ability to adapt and thrive in a constantly changing business environment
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.emdgroup.com/en/company/press-positions.html
If you are a resident of NYC, Connecticut or Colorado, you are eligible to receive additional information about the compensation and benefits, which we will provide upon request. You may contact 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday, for assistance.
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.
As an employee of the Company, you will be required to comply with all of the Company’s COVID-19 safety protocols and policies. The organization has currently suspended enforcement of its COVID-19 Vaccination Policy, but that policy may be reinstated by the Company in its discretion.