Philips Director- Quality Operations 

United States, Colorado, Colorado Springs 

821232140

Director- Quality Operations

Your Role:

• Responsible for Leading, Supervising, Developing and budgetary management for the Image Guided Therapy Devices (IGTD) Quality Operations team supporting acceptance activities, manufacturing, complaint investigations, labeling, packaging, calibration, sterilization, NPI and microbiology.
• Will provide direction and partner with cross functional teams in root cause analysis and issue resolution related to manufacturing, quality management systems, and compliance. Responsible for overseeing tracking and trending of the site’s quality performance data and provides direction on issue resolution for negative trends and results.
• Will serve as the subject matter expert for the site’s quality metrics (nonconformances, CAPAs, complaint investigations, training, etc), operating procedures, and work instructions for internal discussions and internal and external audits.
• As part of continuous improvements to the quality management system, optimizes, reviews and approves procedures, work instructions, protocols and reports for the manufacturing site, including but not limited to process validation and equipment qualifications.
• Will partner with Business and Operations team members in product transfers, new product development and continuous improvement projects, as well as manufacturing and supply chain in product quality improvements, including but not limited to product yield and Cost of Non-Quality measures.
• Establishes and manages the necessary quality programs to meet the Quality System and Quality Assurance needs per company procedures and applicable federal regulations and international standards
• Work with cross functional teams on operations quality mentorship programs, development and succession planning and manages quality budget in accordance with Philips requirements

You're the right fit if:

• You have a minimum of 10+ years’ Quality Operations experience within FDA regulated medical device environments, with a focus on manufacturing, complaints/PMS, labeling, packaging, calibration, sterilization, NPI and microbiology, with a minimum of 5+ years’ experience in Strategic-Functional leadership, change management, people development and budgetary management for Operations quality teams/organizations.
• You have detailed knowledge of cGMP, GDP, FDA and ISO13485 requirements.
• You have the proven ability to work with senior/executive leaders and engage/influence cross functional leadership teams.
• You’re proactive, detail-oriented, and comfortable in a fast-paced company environment and able to adjust workload based upon changing priorities
• You’ve earned a minimum of a Bachelor’s Degree (required) in Life Sciences, Engineering, Quality or related disciplines. Master’s degree desired. ASQ CQE, CBA, or CQA and Six Sigma certifications-preferred
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this .

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

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Philips Transparency Details:

• The pay range for this position in Colorado Springs, CO is $153,000 to $246,000.

Additional Information

• US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.
• Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Colorado Springs, CO.