Quality Engineer

4 weeks ago

Fremont, United States Katalyst Healthcares and Life Sciences Full time
Summary:
  • Responsible for ensuring that materials, goods, and services meet Customer and Quality requirements.
  • Maintains the Quality System to comply with regulatory requirements.
  • Leads continuous quality improvement activities.
  • This is a hands-on position that works with Customers and all functions and levels within the company.
Job Description:
  • Quality Management System
  • Maintain the Quality Management System procedures and work.
  • instructions to comply with Customer and Quality/Regulatory requirements.
  • Work with all functions to ensure compliance with requirements.
Supplier Management
  • Manage the Supplier Management program.
  • Initiate Supplier Evaluations and perform Supplier Approvals
  • Conduct Supplier Audits
  • Maintain the Approved Supplier List
  • Develop Supplier Quality Measures and work with Suppliers to improve performance.
  • Maintain an effective Supplier Corrective Action process.
  • Identify opportunities for supply chain improvements. Implements process.
  • improvement to increase quality and yields at suppliers.
NCMR
  • Manage the Non-Conforming Materials Process
  • Works with Customers, Suppliers, and internal personnel to resolve.
  • nonconforming materials issues
  • Prepare non-conforming material reports and participate in subsequent.
  • root cause investigation and corrective action planning.
Incoming Inspection
  • Participate in and support the Incoming Inspection function.
  • Develop incoming Inspection requirements.
  • Manages the Calibration and Preventive Maintenance process.
  • Coordinates the calibration of equipment with the Calibration Service
  • Works with personnel and Customers to ensure that all equipment is
  • calibrated and maintained.
  • Ensure that all internal calibrations are performed per requirements.
  • Participate in New Product Introduction teams to ensure customer and
  • regulatory requirements are met.
  • Manage the Corrective & Preventive Action System including responding to
Customer Complaints
  • Develop and prepare QMS metrics to monitor the performance of internal.
  • processes for Customers, and Management
  • Manage the Document Control process for Quality Management System documentation.
  • Prepare materials for, and participates in Management Reviews
  • Facilitate the Internal Audit program and conduct audits of the QMS.
  • Facilitate and manage Customer, Notified Body, and Regulatory Audits
  • Work with all functions to ensure Training is conducted per requirements.
  • Performs Release to Finish Goods and Authorizations for Distribution
  • Drives improvements by facilitating cost and quality improvement projects.
Knowledge and Skills:
  • Demonstrated ability to work well in a cross-functional team environment and clearly communicate the status of assigned projects.
  • Ability to work under tight deadlines and to handle multiple detail-oriented tasks simultaneously.
  • Excellent oral, written, and people skills.
  • Demonstrated high level of computer literacy - proficient in developing.
  • spreadsheets, utilizing word processing and databases (MS Office)
  • Proficient in performing Corrective and Preventive Actions
  • Proven analytical ability and attention to detail.
  • Ability to work proactively with suppliers to improve product quality and quickly. resolve quality issues.
  • Understand and be proficient in the use of incoming inspection equipment.
  • Knowledge of theory and application of principles of statistics, statistical sampling techniques, and statistical process control.
  • Knowledge of, and experience with sterile medical device controls and requirements would be a benefit.
Education and Experience
  • Bachelor degree in Engineering, prefer Industrial, Manufacturing, or Mechanical
  • 5 plus years of Quality Engineering experience
  • Required Medical Device Experience
  • Comprehensive knowledge of ISO 13485 and 21CFR820
  • Auditing experience is required.

In addition, experience with the following would be beneficial:
  • Contract Manufacturing
  • Lean Manufacturing
  • Process Validations
  • Software Validation
  • Risk Management
  • AS9100
  • ITAR
  • RoHS

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