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Quality Systems Engineer/Manager

San Jose, CA 95134

Posted: 07/20/2021 Employment Type: Contract To 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.

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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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