Director- Quality Operations

Philips Iberica SAU; Colorado Springs (CO); On-site; USD 153,000 - 246,000; Full time

Job summary

An established industry player is seeking a Director of Quality Operations to lead quality initiatives at their Colorado Springs facility. This role involves overseeing quality assurance, managing complaint investigations, and ensuring compliance with FDA regulations. Ideal candidates will have extensive experience in quality operations within regulated environments and a strong background in developing teams and managing budgets. Join a forward-thinking organization dedicated to improving healthcare quality and making a real impact in the lives of patients.

Benefits

Generous PTO

401k (up to 7% match)

HSA with company contribution

Stock purchase plan

Education reimbursement

Qualifications

• 10+ years in Quality Operations within FDA regulated medical devices.
• Knowledge of cGMP, GDP, FDA and ISO13485 requirements.

Responsibilities

• Lead and manage quality operations for medical devices.
• Oversee quality performance data and issue resolution.

Skills

Quality Operations

cGMP

FDA regulations

ISO13485

Change management

People development

Budgetary management

Root cause analysis

Education

Bachelor's Degree in Life Sciences

Master's Degree

ASQ CQE, CBA, or CQA certifications

Job description

Job Title

Director- Quality Operations

Job Description

As an important member of the CO Springs Operations Management team, the Director-Quality Operations is responsible for leading all aspects of quality manufacturing, complaint investigations, calibration, microbiology, and quality assurance/acceptance activities for Philips Image Guided Therapy Devices (IGTD) Colorado Springs site.

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 ofcGMP, 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 position.

How we work together:

We believe that we are better together than a part. For our Office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company’s facilities. Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations. This is an Office role.

About Philips:

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.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Learn more about our culture.

Philips Transparency Details:

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

The actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

In addition, other compensation, such as an annual incentive bonus, sales commission or long-term incentives may be offered. Employees are eligible to participate in our comprehensive Philips Total Rewards benefits program, which includes a generous PTO, 401k (up to 7% match), HSA (with company contribution), stock purchase plan, education reimbursement and much more. Details about our benefits can be found here.

At Philips, it is not typical for an individual to be hired at or near the top end of the range for their role and compensation decisions are dependent upon the facts and circumstances of each case.

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.

#LI-PH1

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.