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Quality Systems Engineer/Manager

San Jose, CA 95134

Posted: 07/20/2021 Employment Type: Direct Hire Industry: QA/Testing Job Number: 23299

Job Description


Position Title: Quality Systems Engineer/Manager

Position Description: Protingent Staffing has an exciting contract to hire opportunity for a Quality Systems Engineer/Manager with our client located in San Jose, CA

Job Responsibilities:
  • Responsible for operating the  Quality Management System (QMS), writing procedures and processes to support the  QMS  development.
  • Lead and undertake audits across all areas of the business as well as across the supply chain.
  • Support the implementation of new processes and procedures, including the selection and implementation of a new electronic QMS and maintenance all QMS content and master files.
  • Assist and ensure the Quality Management System and regulatory compliance requirements are effectively maintained, implemented and monitored.
  • Monitors Quality issues, identifies actions needed to correct, highlights issues to management and drives corrections.
  • Interfaces with R&D and Operations and other area Managers to implement process improvements.
  • Monitors compliance with standard operating procedures and ISO/QSR requirements.
  • Provide continuous assessment of the Quality Management System including CAPA, internal audit, management reviews and other related processes to ensure compliance requirements.
  • Identify gaps, enhancements and create/establish process checklists/forms, work instructions, non-conformance reports and ensure all quality check procedures are put in place.
  • Assist with corrective actions, process investigations and implementation activities.
  • Participate and lead internal compliance audits and on-site audits of customers and vendors.
  • Administer the Corrective and Preventive Action Systems for customer feedback, supplier conformance and internal continuous improvement projects.

Job Qualifications:
  • BS Engineering (preferred) or related technical area, or 2-5 years of Quality Systems or Engineering experience.
  • Knowledge of and 2-5 years of experience with Quality Systems regulations including 21 CFR 820 and ISO 13485.
  • High level of experience and understanding of GMP/GLP system requirements
  • Experience with the execution of quality systems like CAPA, NCMR, deviations and document control.
  • Certified Internal Auditor (preferred)
  • Excellent skills in organization, record keeping and oral and written communications

Benefits Package: Protingent offers competitive salary, 100% paid health insurance, education/certification reimbursement, pre-tax commuter benefits, Paid Time Off (PTO) and an administered 401k plan.

About Protingent: Protingent is a niche provider of top Engineering and IT talent to Software, Electronics, Medical Device, Telecom and Aerospace companies nationwide. Protingent exists to make a positive impact and contribution to the lives of others as well as our community by providing relevant, rewarding and exciting work opportunities for our candidates.

 

Meet Your Recruiter

Nick Vella

In 9 years of recruiting my style can be described as being direct, detailed, persistent. I will provide you with all necessary info needed to make the best decision for yourself. Each of my candidates that I’m representing is my #1 priority. I work around the clock to move a process along, to search and network for other potential opportunities to pitch a candidate to. The entire recruiting cycle process is all about creating a smooth experience for both the candidate and client. I feel I do that by my attention to detail, organization and ability to communicate effectively with each individual candidate. On my time off, I love to cook for my wife and 2 kids and ran my first Triathlon this April in Napa.

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