Quality System Specialist III

Posted 21 Feb 2019

Temecula, California - United States

Req Id 187602

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 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.


Your Role:

  • Maintain a compliant Supplier Quality system in accordance with the Divisional Quality and Site Quality Management System and applicable standards and regulations.
    • Coordination of the site Supplier Quality program. Ensure that supplier qualification, assessments and audits are scheduled and executed in compliance with local, divisional, and corporate requirements.
    • Serve as the primary contact for Supplier Quality System internal and external customers, approval of processes, approval of documentation changes and development/improvement projects.
    • Execute Supplier measurement and feedback program.
    • Provide metrics and reports to site Supervisor upon request.
  • Provide technical support to internal and external customers in the achievement of a compliant Quality Management System, product quality and, as appropriate, communicates with the site Supervisor any potential process and/or product deficiencies.
  • Lead and direct Investigative, RCA and CAPA support as identified through the site audit system.
  • Responsible for interacting cross-functionally to support Purchasing/Manufacturing/Production deadlines and product delivery schedules.
  • Participates in quality improvement projects utilizing Lean, Kaizen, and Six Sigma approach in conjunction with Operation Excellence group to develop improvements.
  • Assist in providing support for performing internal quality system audit(s).
  • Assist in providing support for Design/Development and New Product Introduction/Technical Transfer and/or Engineering programs.
  • Writes and revises Standard Operating Procedures as needed.
  • Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks.
  • Able to work well in a team environment.
  • Ability to work and communicate effectively with all areas and levels of the organization.
  • Excellent analytical skills.
  • Excellent oral and written communication skills.

May be required to perform additional duties as assigned.

Who You Are:

Basic Qualifications:

  • Bachelor’s degree in Life Sciences or Engineering required.
  • 5 years in Quality or Lab Sciences with 3 years working in a Class II or Class III drug manufacturing, medical device, or biologics industry in Quality Assurance or Quality Engineering position.
  • 3 years of experience working with QSR’s, ISO 9001, ISO 13485
  • Ability to travel up to 20%, including air travel internationally.

Preferred Qualifications:

  • Experience in Audit and Supplier Quality procedures highly preferred.
  • 2 years solving complex problems related to quality system issues, production, customer and/or supplier related concerns highly preferred.
  • 1+ years working with statistical data or project planning preferred.
  • Certified Quality Auditor and/or Certified Quality Engineer preferred.

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfill your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
 

Curious? Apply and find more information at come2emd.com

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 his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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