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Head of Quality - Rocklin
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.
The MilliporeSigma facility in Rocklin, CA manufactures In Vitro Diagnostic Medical Devices that are regulated and subject to inspection by the US FDA and other notified regulatory bodies. The Head of Quality is responsible for all aspects of the site Quality organization, the Site Quality Management System (QMS), and is a member of the Site Leadership Team.
The Head of Quality provides leadership and strategy to ensure that all products and services provided conform to relevant quality standards, regulations, and customer/regulatory specifications; ensures that a compliant Quality Management System (QMS) and supporting processes are established, effectively implemented, and maintained; supports the Head of Operations to develop a site culture of compliance excellence. The Head of Quality is the final site decision point for all Quality related issues.
You Will be Responsible to (including but not limited to):
- Report to top management on the performance of the QMS, including needs/ideas for improvement, and promotes awareness of regulatory and customer requirements throughout the organization; serves as the management representative to external regulatory agencies; drives improvement activities and maintains comprehensive Quality metrics
- Develop, manage, and maintain the site Quality Management System (QMS) in accordance with applicable Regulatory requirements (US FDA 820, MDSAP, IVDR and any other applicable regulations) and International Quality Standards (ISO 13485 and any other applicable standards); exercise the authority and the responsibility to implement and maintain an appropriate QMS
- Lead, manage, and develop the Quality Assurance (QA) and Quality Control (QC) functions to ensure product realization and maintenance of the QMS; ensure implementation of team objectives aligned with Corporate, Site Quality, and business goals; direct and oversee all department staff in the performance of their respective duties, and complete related HR activities including interviewing, performance management, and disciplinary tasks
- Partner with Manufacturing, Regulatory Affairs, and other related support teams to make recommendations, set goals, and implement solutions for process improvements and maintaining compliance. Provides overall guidance on Quality and ensures business objectives are met
- Ensure that manufacturing and testing operations conform to applicable quality standards, regulations, and customer/regulatory specifications by implementing the necessary systems, procedures, documentation, and training to maintain compliance
- Ensure that approved product, process and raw materials specifications, quality and regulatory requirements are met; be responsible for all products released into inventory; exercise authority to place product on hold, or prevent shipment of product, where a product quality concern has been raised
- Ensure that site staff understand and comply with applicable Quality standards and regulatory requirements including identifying training needs, developing training materials, and providing training and support to site staff
- Promote awareness of regulatory and customer requirements throughout the organization
- Cultivate a site culture of compliance excellence and continuous improvements; provide expert guidance and consultation to operations management in the areas of compliance and industry expectations
- Act as the Person Responsible for Regulatory compliance as applicable for site IVDR certification requirements
- The Head of Quality position is located onsite in Rocklin, CA and cannot be performed remotely
Who You Are:
- Bachelors degree or higher in a scientific discipline
- 7-12 years’ experience leading a quality organization in a technical manufacturing environment.
- Demonstrated command of Quality Management Systems (QMS) supporting ISO 9001, and ISO 13485 certifications as well as FDA regulations (such as CFR820) in support of medical device class I-III products and EU IVDR Regulations.
- CQE, CQA, CQPA, CBA, CMQ/OE certifications strongly preferred
- Exceptionally strong leadership skills
- Strong foundation in Lean Manufacturing and Continuous Improvement; LSS Black or Green Belt certification strongly preferred
- Proven problem-solving ability with ability to engage root cause analysis
- Exceptional organizational skills
- Ability to motivate and build a high performing team
- Strong written and verbal communication skills
- Collaborative team player with ability to drive change and challenge the status quo
- Ability to set ambitious and achievable targets to drive results based on organizational objectives
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.