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Quality Engineering Supervisor
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.
The Quality Engineering Supervisor will support device manufacturing at the Jaffrey Manufacturing site at MilliporeSigma. They will manage a small team of Quality Engineers and Quality Technicians and oversee three rapidly growing manufacturing work centers, partnering with Operations, Engineering, Product Management (Marketing) and EHS.
The candidate will apply crucial fundamental engineering techniques and lean/six sigma principles to enhance product performance. The Supervisor will provide guidance and mentorship to his/her expanding team of quality engineers and quality technicians.
In addition to the supervisory requirements, the candidate will also be responsible for providing day-to-day Quality Engineering support for a fast-paced device manufacturing operation, including:
- evaluate of out-of-specification conditions and providing guidance for the disposition of non-conforming product and raw materials,
- lead quality investigations (RCA and CAPA management)
- perform statistical analysis and trending to assess and monitor product/process performance,
- work with cross functional teams to set the requirements to support product and process modifications; ensuring that Change Control requirements are met based on internal company procedures and applicable industry standards and regulations
- lead and participate in the creation of risk assessments (product and process- FMEA)
- participate in product validation and equipment qualifications by establishing acceptance criteria, statistical sampling plans, data analysis, and write validation protocols and reports
- create / revise Standard Operating Procedures, Test Methods, and other documents
Who You Are:
- Bachelor's Degree in a scientific, engineering, or technical discipline
- 3+ years of Quality Engineering experience
- 2+ years leadership experience in an FDA regulated environment (pharmaceutical, biotechnology, or medical device)
- Understanding or experience with ISO & FDA regulations (such as 21 CFR 820, 210 & 211).
- Demonstrated ability to conduct quality investigations including root cause analysis and determining corrective / preventative actions.
- Demonstrated ability to create and update standard operating procedures.
- Strong communication skills with the ability to collaborate with Customers and at all levels and functions of the organization.
- Pragmatic risk-based decision maker with strong problem-solving ability.
- Collaborative and motivated team player. Always looking to share and advance best practices.
- Experience with relevant data analysis software (i.e., Minitab).
- Working knowledge of Electronic Quality Systems (CAPA, Change Control, Documentation Management)
- Black Belt or Green Belt.
- ASQ CQE.
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.