Quality Engineer I

Posted 23 Jul 2022

Rocklin, California - United States

Req Id 251299

Details

 

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.


 

Your Role:  

Under management supervision, the Quality Engineer I is directly responsible for maintaining the Quality System in compliance with company procedures and regulation standards; providing GMP support for all operations; supports the audit process.

Responsibilities include but are not limited to:

 

  • Conducts deviations, CAPAs, PAs, and audit investigations for determination and implementations of corrective and preventive actions.
  • Supports timely completion of field action, MDR, and/or adverse event reporting.
  • Quarantines and monitors the disposition of nonconforming product in support of deviation investigations, and coordinates MRB meetings.
  • Contributes to maintaining a quality system that is compliant with the ISO 13485, Canadian MDR requirements, FDA cGMP standards, foreign country product registrations, and CE Mark to comply with European Union IVDD.
  • Develop, facilitate, and implement change controls utilizing the Trackwise system.
  • Performs monitoring and measuring activities as assigned for processes as related to quality and regulatory issues.
  • Provides process data to create quality metrics to assess the quality system’s performance and efficacy.
  • Generates metrics and reports out to management.
  • Writing process validation plans, protocols, reports and being involved in the development and improvement of manufacturing processes.
  • Completing process requirements documentation, understanding the validation strategy for medical devices (IVD and ASRs), writing, and executing test method validations, and maintaining the validation master plan.
  • Provides specification, procurement, installation, start-up, and commissioning activities for manufacturing equipment, facilities areas, and process utilities systems.
  • Reviews Manufacturing and Product Device History Records (DHRs) to ensure compliance with quality system and regulatory requirements.
  • Writes, revises, and/or reviews Standard Operating Procedures (SOPs) while adhering to regulatory requirements.
  • Maintains knowledge of SOPs and GMP regulations and guidelines.
  • Maintains cGMP compliance.
  • Maintains and demonstrates a high level of personal and professional integrity and reports any suspicious activity to management.
  • Working extended hours and/or on weekends as needed.
  • Additional duties as needed to support business needs.

 

Who You Are:

Minimum Qualifications:

  • High School Diploma or GED.
  • 3+ years of experience in an FDA, ISO, GMP, or other regulated manufacturing environment within a Quality Assurance/Quality Control role.

 

Preferred Qualifications:

  • Bachelor’s Degree in Biology, Chemistry, Biochemistry, or other Life Sciences discipline.
  • General knowledge of FDA, QSRs, cGMP, ISO 13485, or other related industry standards.
  • General understanding of the principles and practices of managing a product line from research and development phase through distribution.
  • Management of deviations and CAPA’s within Quality Systems using Trackwise or other QMS software and reporting associated metrics to management.
  • Strong level of proficiency using SAP within a manufacturing setting.
  • Knowledge and use of PC software applications (MS Word, MS Excel, and Adobe) and skills to use them effectively.
  • Excellent organizational, time management, and project management skills.

 

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.

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