Quality Engineer (Irvine, CA) $95-110K+

SNAPSHOT!

Looking to join a cutting edge medical device team that is paving the way in a very unique product line? Read on! The Quality Engineer will be responsible for supporting supplier quality, releasing ‘lots’ of received inventory/parts and with setting up new manufacturing lines. You'll collaborate with cross-functional teams from manufacturing, operations, quality to make improvements in supplier quality and role out of new manufacturing lines. The ideal candidate will be a hands-on quality engineering expert who drives the continuous improvement of innovation, quality, delivery and productivity within the organization

Immediate Opening for a Quality Engineer who possesses:

• Your BA/BS Engineering-oriented degree and 2+ years of experience in medical device manufacturing.

• Plan and execute quality-related maintenance and improvement activities related to devices as well as qualification of in-house materials to prevent or minimize quality issues
• Develop and improve manufactured parts inspection strategies based on establishment, implementation and improvement of related quality metrics and monitoring of critical to quality indicators
• Communicate effectively with internal counterparts regarding product related CAPA and other quality issues. Evaluate impact of proposed component, product and process change requests; lead cross functional teams to identify and execute appropriate actions.
• Lead CAPA and NCMR investigations and support investigation teams relating to product functionality and design improvement.
• Collaborate with the Operations Engineers to determine the qualification and requalification activities for equipment qualification and process validation, process capability, test method validation and ISO 14971 risk management activities and process improvements.
• Support the Supplier Quality Team in supplier selection, evaluation and qualification of supplied components and devices.

• Facilitate compliant and timely process deviation, change control and quality planning activities.

Key Responsibilities include:

• Understanding of and ability to interpret and apply ISO 13485, ISO 14971, and 21 CFR Part 820, specifically design controls, purchasing controls, risk management and production and process controls
• Proficiency leading CAPA investigations and supplier corrective actions
• ASQ Certified Quality Engineer, preferred
• Strong proficiency using MS Office Suite (e.g., Word, Excel, PowerPoint)
• Excellent written and verbal communication skills Results-oriented with appropriate urgency and follow-up
• Ability to work as a collaborative team member as well as independently Excellent attention to detail, producing high quality output
• Flexibility and strong organizational skills with ability to prioritize multiple tasks
• Applies sound judgment when making decisions and communicating with internal and external customers
• Strong interpersonal relationship skills including negotiating and relationship management

Compensation Includes:

• $95-110K Base DOE, with bonus potential

For immediate consideration, please send your resume to info@venturehiregroup.com!