Quality Engineer

  • San Francisco
  • Permanent
  • Mon Feb 12 16:26:42 2018

Quality Engineer- Manufacturing

Location: Bay Area

Relocation Assistance is not offered for this position

The HT Group is currently seeking a Quality Engineer in the San Francisco Bay Area for a Surgical Robotics Company. This position will be responsible for day-to-day administration of the QMS and in the development, implementation, and maintenance of QMS processes to meet the requirements of U.S. FDA and other applicable quality and regulatory standards.

REQUIREMENTS

• BS or MS degree in Mechanical, Biomedical or Electrical Engineering

• Minimum of 5 years Quality Engineering experience in Quality Assurance or Product Development activities in medical device industry

• Must have working knowledge of CFR 820, ISO 13485, MDD, ISO 14971, IEC 60601-01

• Demonstrate accuracy and thoroughness to improve and promote quality; apply feedback to improve performance; and monitor own work to ensure quality

• Knowledge of Quality Management Systems, Quality procedures, and application of Quality Tools (e.g. 8D, SPC, Yield Analysis, etc.)

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Provides quality support to day-to-day manufacturing activities including NCMRs, Process Deviations, Drawing and manufacturing document changes, in-process and final inspection and testing, etc.

• Design and develop quality processes, inspection, and test systems that yield predictable product quality results

• Develop, write and/or update processes for component, sub-assembly, and product inspection and testing

• Assist with manufacturing process activities including process FMEAs, process validations, supplier qualifications

• Identify processes critical-to quality and create inspection and test methods to control such processes

• Work with manufacturing, R&D, and supply chain teams to improve product performance • Perform process capability studies and create process control plans for key components and processes

• Participate in transferring new products from R&D into production following project management strategies

• Drive continuous improvement through monitoring of quality data and ongoing assessments

• Participate in cross-functional teams for quality improvement initiatives

• Participate in and support Continuous Improvement initiatives

• Identifies and controls Manufacturing process defects (scrap, nonconforming material, customer complaints) by participating in efforts/teams focused on identifying the primary root causes and implementing corrective and preventative actions

• Develops Process Monitoring Systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects

• Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented

• Review drawings/procedures for technical accuracy, and update as required

*Please Attached Resume to Application*