Sr. Director of Quality

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Position Summary:

The Sr Director of Quality will lead the creation and execution of a robust Quality function. This role will be instrumental in shaping the quality framework, building essential systems, processes, and a high-performing team to enable and sustain rapid growth. The position supports a progressive medical device contract manufacturing organization from components through finished devices.

• Provide strategic leadership and direction for the Quality Department, including vision, priorities, metrics, and overall achievement of organizational goals.
• Serve as a member of the business leadership team, driving the quality vision and contributing insights to enhance overall business results.
• Build and develop a high-performing team through selection, performance management, coaching, and mentoring.
• Drive continuous improvement across the organization through effective Quality Systems, lean methodologies, and best-in-class practices.
• Ensure Quality Systems meet U.S. and global regulatory requirements for research, development, manufacturing, and commercial activities for a medical device contract manufacturer.
• Maintain and improve Quality governance, metrics, and processes to align with business and compliance needs.
• Serve as Management Representative for regulatory and customer audits, including supplier/vendor qualification and inspection management.
• Identify strategic business and Quality System issues and implement effective, timely changes.
• Apply analytical and statistical methods (e.g., design of experiments, process validation, root cause analysis) to improve processes and reduce the cost of quality.
• Develop and manage the department's operating budget and recommend capital expenditures.

• Bachelor's degree in a relevant field; advanced degree preferred.
• 15+ years of progressive quality leadership experience, including at least 10 years in senior management roles.
• Proven track record of developing and executing quality strategies in complex manufacturing environments.
• Expertise in FDA regulatory affairs, with demonstrated success navigating global regulatory landscapes.
• Strong strategic problem-solving skills with the ability to influence cross-functional leadership teams.
• Experience building and leading high-performance teams to achieve measurable quality and business results.
• Proficiency in quality systems, inspection methodologies, and advanced measurement technologies (e.g., Coordinate Measuring Machines, SmartScopes).
• Demonstrated ability to leverage technology, data, and metrics to drive decision-making and continuous improvement.
• Exceptional verbal and written communication skills, with the ability to present to executive leadership, regulatory agencies, and customers.
• High level of organizational agility with the capacity to prioritize and execute in dynamic, fast-paced environments.
• Experience managing budgets, capital planning, and quality-related investments.
• Commitment to fostering a culture of quality, compliance, and operational excellence across the enterprise.
• Ability to work in a manufacturing environment.

Preferred Requirements:

• Experience in contract manufacturing
• Continuing Education; including participation in local chapters, associations, and/or organizations

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• "The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right."
• "I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it."
• "I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives."

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.