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Quality Systems Specialist II

Your Role: 

  • Maintain a compliant Audit Management system in accordance with the Divisional Quality and Site Quality Management System and applicable ISO 9001, ISO 13485 and FDA QSR and applicable Good Manufacturing Practices (GMP) to primarily entail:
    • Coordination of the site Audit Management program.  Ensure that internal audits are conducted and recorded in compliance with local, divisional, and corporate requirements.
    • Serve as a lead internal auditor.
    • Serve in the approval of process and documentation changes and development/improvement projects relating to the Audit Management program.
    • Provide Investigative, RCA and CAPA support as identified through the site audit system.
    • Monitor trends in site audit findings and provide metrics and reports to site Supervisor upon request.
  • Assist in customer complaint handling and provide Investigative, RCA and CAPA support as identified through the site complaint system.
  • Provide technical support to internal and external customers in the achievement of product quality and, as appropriate, communicates with the site Supervisor any potential product deficiencies.
  • Responsible for interacting cross-functionally to support Technical and Customer Services/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 Design/Development and New Product Introduction/Technical Transfer and/or Engineering programs.
  • Writes and revises Standard Operating Procedures as needed.
  • May be required to perform additional duties as assigned.
  • Occasionally travel 5% of the time.


Physical Attributes:

  • Much of the work will be in a production environment.
  • Ability to clearly and comfortably view, interpret and process information via a computer monitor for extended periods of time during normal working hours is required.  Some assignments may require extended periods in another plant/office location. 


Who You Are:


Minimum Qualifications:

  • Bachelor’s Degree in Life Sciences or in a Scientific discipline
  • 2+ years of experience in Quality or in an FDA regulated industry
  • 1+ years of experience in a Class II or Class III drug manufacturing, medical device, or biologics industry in Quality Assurance or Quality Engineering position


Preferred Qualifications:

  • Experience in Audit and Complaint Management processes and procedures
  • Strong understanding of QSR’s, ISO9001, ISO 13485
  • Strong statistical knowledge and/or project planning skills needed.  Ability to solve complex problems related to quality system issues, production, customer and/or supplier related concerns.
  • 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.
  • Self-directed and self-motivated with excellent organizational skills with ability to prioritize and work effectively on multiple tasks.



Job Requisition ID:  211944
Location:  Temecula
Career Level:  D - Professional (4-9 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

US Disclosure
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
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Nearest Major Market: Riverside
Nearest Secondary Market: Los Angeles

Job Segment: Medical, CAPA, Lean Six Sigma, Quality Manager, Healthcare, Quality, Management

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