QA Director - Software Engineering - GE Healthcare - Barrington

Job description
The Quality Assurance Director - HCIT Engineering, as an active member of the management team, is responsible for creating and supporting a Quality culture across sites by driving compliance activities around the Healthcare IT products. This includes being responsible for the engineering component of quality management system for the business and driving Quality.

Essential Responsibilities:

• Ensuring all design controls procedures are followed across HCIT Engineering including but not limited to design history files, design change, verification and validation, etc.
• Liaising for HCIT into GE Healthcare Engineering counsels
• Partnering with the Engineering teams across HCIT to ensure proper training and adherence to design control
• Build competency and skills across the entire HCIT Quality Assurance organization
• Having the authority to issue concessions, stop production, make decisions about people and budget accountability, and provide input during the Session C process
• Leading and driving specific product compliance across poles/sites--owns the Corrective and Preventive Actions process and training, employee training and development, internal audit programs, and the new product introduction (NPI) milestone approval process
• Accountable for each of the metrics for the business (i.e. complaint investigation, internal audit score, product quality, employee engagement, etc.) and management review process
• Influencing hiring decisions, product compliance process development, and new product introduction (NPI)
• Serving on Global or functional Quality Council(s)

Desired Skills and Experience
1. Bachelor’s degree
2. 12 years Quality Assurance/Regulatory Assurance experience
3. 5 years experience in the medical device or pharmaceutical industry
4. 2 years supervisory/management or project leadership experience
5. Demonstrated knowledge of Quality Systems (demonstrated experience with ISO, GxP, FDA and other key regulatory bodies) and experience with new product introduction process (NPI)
6. Knowledge of and exposure to manufacturing or engineering processes
7. Ability to communicate using English (or local language)
8. Prior experience using word processing, spreadsheet, and presentation software

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