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Quality Systems Specialist III
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 senior level position shall oversee system upgrades, lead business critical improvements, and provide support to the sites Quality Management System (QMS) for compliance, reporting to the Quality Systems Manager. The individual will lead projects that are intended to improve efficiencies, reduce overall site risk and ensure compliance with all internal and external requirements. The Quality Systems Specialist III will generate project plans, lead cross-functional teams to achieve assigned objectives and report status to leadership.
- Comprehensive understanding and application of QMS in the Life Science industry and ISO 9001:2015 principles.
- Create project charters to identify internal/external compliance requirements and stakeholders. Lead cross-functional teams to achieve project objectives.
- Ensure effective assessment and analysis of all activities will achieve desired outcomes and minimize potential for site impact or disruption.
- Utilize all existing Quality Management Systems to document activities and communicate these activities to all appropriate site personnel.
- Support other Quality Systems as needed.
Who you are:
- High School Diploma or GED
- 10 + years-experience in a manufacturing environment with FDA 21CFR820 or ISO 9001 compliance.
- Bachelor of Science degree in Engineering, Life Sciences, or related field
- Excellent communication skills, both written and oral, with the ability to collaborate at all levels and functions of the organization and with customers.
- Leadership experience, the ability to gain consensus with groups.
- Subject matter expert regarding ISO 9001:2015 principles.
- Working knowledge of electronic Audit, Deviation, CAPA and Change Control systems.
- Self-directed and self-motivated
- ASQ Certified Quality Process Analyst (CQPA)
- Lean Six Sigma certification
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.