Quality Compliance Specialist

Posted 12 Dec 2022

Rocklin, California - United States

Req Id 259148

 

Work Your Magic with us!

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 MilliporeSigma Rocklin, CA facility manufactures In Vitro Diagnostic Medical Devices that are regulated and subject to inspection by the US FDA and other notified regulatory bodies. The Quality Compliance Specialist is responsible for providing support for medical device products (IVD’s and IVDR) at the Rocklin site to ensure compliance with regulatory standards including FDA, ISO 13485, MDSAP, and IVDR requirements. The Quality Compliance Specialist works closely with Regulatory Compliance and R&D to support applicable IVDR submissions and coordinates and leads IVDR, ISO 13485 and MDSAP Audits to ensure audit responses are completed in an accurate and timely manner.

 

Who You Are:

 

Minimum Qualifications:

  • Bachelor’s Degree in Life Science, Biotechnology, or other discipline
  • 5+ years’ experience in Quality Compliance or Regulatory roles

 

Preferred Qualifications:

  • Experience demonstarating command of Quality Management Systems supporting ISO 9001 and ISO 13485 certifications and 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
  • Exceptionally strong leadership skills
  • Strong ability to communicate effectively verbally and in writing with all levels of staff and internal/external stakeholders
  • Proven problem-solving skills with ability to engage root cause analysis
  • Exceptional organizational skills
  • Exceptional time management skills
  • Ability to motivate and work with cross functional teams for successful outcomes
  • 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
  • Ability to make timely decisions with sound and accurate judgement
  • Ability to effectively manage multiple projects/tasks with varying requirements and deadlines
  • Proficient in Microsoft Office

 

Pay Range for this position - $49,500 - $148,900

 

Our ranges incorporate all levels and career types available within this specific role, and are derived from relevant industry market data.  Should we decide to make an offer, we will consider several factors, including but not limited to your location, skills, experience, career level, and other job-related factors.  This role may offer the following benefits: medical, vision, and dental insurance; life insurance; disability insurance; a 401(k) matching program; paid time off; and paid holidays; among other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including, but not limited to, cash bonuses.

 



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 and believe that it 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!
 
Apply now and become a part of our diverse team!

 

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


Equal Employment Opportunities

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.

North America Disclosure

If you are a resident of Colorado or New York City, 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.

Notice on Fraudulent Job Offers

Unfortunately, we are aware of third parties that pretend to represent our company offering unauthorized employment opportunities. If you think a fraudulent source is offering you a job, please have a look at the following information: https://www.emdgroup.com/en/careers/faqs.html

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