Quality Systems Engineer/Manager
128 Baytech Drive San Jose, CA 95134
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
- 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.
- 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.