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Mfg/Ops Quality Engineer 1

San Diego, CA 92122

Posted: 12/03/2024 Employment Type: Contract Job Category: Engineering Job Number: 615860 Is job remote?: No Country: United States

Job Description


Target Pay Rate: 29.75-37.25/hr **salary will be commensurate with experience 

Responsibilities:
  • Develop global governance of quality system controls in SAP Establish and/or improve system controls in SAP for release of raw material component and final product
  • Develop deliver and drive global QMS projects transition due diligence integration to ensure compliance to applicable regulations and standards
  • Utilize best practice project management to ensure goals objectives and performance metrics are met and/or exceeded
  • Assist in the definition of project scope and objectives involving all relevant stakeholders and ensuring technical feasibility
  • Establish and maintain cross-site communication channels with Quality department stakeholders to assure Quality department alignment
  • Engage SMEs to Validate i.e. vet with SMEs stakeholders and key site
  • Quality personnel all Quality department ERP requirements before configuration
  • Host design reviews specifically addressing key
  • Quality decisions processes and ERP and related configurations
  • Advises and consults on QMS project/quality plans risk assessments and remediation plans
  • Applies sound systematic problem-solving methodologies in identifying prioritizing communicating and resolving quality issues

Requirements:
  • 0-2 years experience in quality assurance field in a regulated environment direct experience working in in-vitro diagnostic manufacturing preferred
  • Knowledge and experience applying quality regulations and standards 21CFR 820 ISO 13485 ISO 14971 IVDD
  • Knowledge and experience with instituting quality controls in an ERP system
  • SAP preferred
  • Highly effective communication facilitation and negotiation skills
  • Adaptable to fast-paced dynamic work environment with shifting demands
  • Bachelor's degree required 
  • 1-2 years of experience 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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About San Diego, CA

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Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.