Quality Assurance Specialist - Supplier Quality, Internal Audit

Posté 24 janv. 2023

Rocklin, California - United States

Demander un identifiant 258727


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 Quality Assurance Specialist - Supplier Quality, Internal Audit provides Quality Assurance process support for the Rocklin site, supporting key Quality Assurance initiatives and deliverables with focus on the overall Quality Management System (QMS), Product/Process Improvement, Supplier Quality Management, and Internal Audits; ensures compliance with current ISO 13485, EU IVD, EU IVDR, and FDA QSR standards; prepares Quality System documents and reports as needed for Rocklin site metrics and management review.

Who You Are:
Minimum Qualifications:

  • High School Diploma or GED
  • 3+ years of Quality professional experience
  • 2+ years’ experience working in a GMP environment

Preferred Qualifications:

  • Bachelor's Degree in a Life Science discipline or Engineering discipline
  • Strong statistical knowledge

  • Project planning/project management skills

  • Ability to solve complex problems related to quality system issues, production, customer, and/or supplier related concerns

  • Strong understanding of QSRs, ISO 9001, ISO 13485
  • General understanding of the principles and practices of managing a product line from research and development phase through distribution
  • Experience in Audit and CAPA procedures
  • Strong analytical skills
  • Excellent written, oral, and interpersonal communications skills
  • Excellent organizational, prioritization, time management, and problem-solving skills
  • Ability to work independently and effectively manage multiple tasks/projects with varying deadlines
  • Highly proficient in MS Office Software (Word, Excel, PowerPoint), and calendaring
  • Ability to effectively work both in a team situation and individually with minimal supervision
  • Ability to travel 10% of the time to support supplier qualifications


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