Our client, a division of a leading global healthcare products company, specializes in medical devices and procedures for vascular therapies.  We are assisting them in their search to fill a new role of Quality Engineering Manager.

Reporting to the Plant QA Manager, and overseeing a team of 4-5 direct reports, the QE Manager oversees the Quality Engineering and Quality Control functions while maintaining compliance to all applicable regulations and standards. This position will require working with manufacturing and product development to improve product quality and reliability to meet customer needs while minimizing overall costs.

The Quality Engineering Manager will:

• Manage all Quality Engineering activities to include Quality Engineering staff for the San Jose, CA site.

• Manage all Quality Control activities.

• Analyze internal and external quality data including manufacturing yields, field complaints and investigations, supplier performance, etc. to help identify and drive corrective and preventive actions required to improve product and process quality.

• Plan, promote and organize training activities related to product quality and reliability.

• Participate in the selection of suppliers, implementing and monitoring supplier quality improvement goals.

• Oversee Process & Product Compliance.

• Continuously monitor processes and product quality data to ensure compliance with customer and internal quality requirements.

• Communicate with manufacturing and engineering to recommend changes to inspection methods, designs, tooling and processes to promote continuous improvements.

• Participate in product support process and monitor production and post-production risk management feedback.

• Provide technical and statistical guidance in the analysis and investigation of customer complaints and responses (action plans) to internal corrective and preventive actions.

• New Product Development and Product Support.

• Participate as a Core Team Member and/or assign a Quality Representative on all Product Development Projects.

• Maintain compliance to all FDA Design Controls.

• Participate in Product Risk Management activities and maintain compliance to the current ISO 14971 Risk Management Standard.

• Review and approve Engineering Change Orders (ECOs) as Quality Systems approver as required.

• Quality Systems

• Provide Quality Engineering review and Risk Management review for ECOs.

• Maintain FDA/ISO Quality System compliance at all times including following all SOP’s.

• Revise / enhance Quality System procedures to meet the needs of the business while maintaining compliance to all applicable regulations / standards.

• Assist the Site Quality Manager in preparing the Quarterly Quality Report and the Management Review Presentation to include presenting data at the Quarterly Management Review meeting.

• Perform internal audits as required.

• Support FDA, ISO, customer and safety agency audits / inspections.

The ideal candidate will have:

• Bachelor’s Degree in Engineering or equivalent education and work experience

• Experience managing direct and indirect employees

• 5 – 10 years related quality experience, preferably in the medical device industry

• Certification by ASQ in one or more of the following: Quality Manager, Quality Engineer and Quality Auditor

• Certification as Six Sigma Black Belt strongly preferred

OTHER REQUIREMENTS:

• Knowledge of Good Manufacturing Practices (GMP) and applicable Quality System Standards.

• Working knowledge through experience and training in the FDA 21CFR Part 820 Quality System Regulation, ISO-13485 Quality Management System and ISO-14971 Application of risk management to medical devices, (current editions).

• Auditing skills gained through experience and training.

• Working knowledge of design and process validation and verification methodologies.

• Other duties as assigned with or without accommodation.

• No medical conditions preventing access to a controlled environment room