Director of Quality & Regulatory

Drucker Diagnostics • Philipsburg, PA

6d • Onsite

About The Position

At Drucker Diagnostics, we know that making people healthier starts with information. Behind every diagnostic test result is a patient waiting to learn what comes next. Our benchtop centrifuges prepare the samples that guide critical healthcare decisions, from routine bloodwork to urgent diagnoses, and support regenerative therapies like Platelet Rich Plasma treatments. When accuracy matters most, laboratories and clinics in over 80 countries trust the instruments we design and build right here in the USA.

We believe that quality is more than a step in the inspection process. It is a commitment built into every process, every decision, and every product. We operate in an environment where our customers depend on us for compliance and precision that directly impact patient outcomes. The Quality and Regulatory Team plays a critical role in protecting that trust and ensuring our products meet the highest standards worldwide. If you want to make a real difference building something truly remarkable, join us.

As the Director of Quality & Regulatory, you will lead the company's Quality Management System and Regulatory strategy to ensure product safety, compliance, and continuous improvement across the organization. This role champions a proactive, prevention-focused quality culture, partners closely with cross-functional leaders, and ensures Drucker Diagnostics meets all applicable regulatory and customer requirements. Your work will directly advance our mission to make people safer, healthier, and more productive.

Requirements

• Always prioritize safety and actively demonstrate safe practices in every task. Follow all safety procedures, proactively report unsafe situations, and wear the required PPE.
• Lead by example in maintaining a safe work environment and encourage your co-workers to do the same.
• A passion for working in a fast-paced, safety-oriented, mission-driven manufacturing environment.
• Demonstrated leadership experience in a regulated quality environment.
• Strong working knowledge of ISO 13485 International Standard, CMDCAS, FDA, EU regulations/directives, and other international regulations as required.
• Proven ability to lead compliance, audits, and continuous improvement initiatives.
• Strong customer focus with the ability to work independently and follow tasks through to completion.
• Excellent organizational, prioritization, and problem-solving skills.
• Strong interpersonal skills with the ability to collaborate effectively across departments.
• Experience with Quality System documentation and good documentation practices.
• Excellent written, verbal, and presentation communication skills.
• Ability to present information to all levels of employees and partners.
• Bachelor’s Degree in Engineering, Chemistry, Biology, or a related technical discipline.
• Minimum of 5 years of experience in an FDA-regulated pharmaceutical, biotechnology, or medical device environment. Previous engineering experience in a medical device market preferred.
• At least 5 years of Quality Assurance experience.
• Or an equivalent combination of education and experience.
• Strong computer skills required for documentation and training.
• Proficiency in MS Office Suite (PowerPoint, Word, Excel, Outlook, etc.)
• Adobe Acrobat proficiency required.

Nice To Haves

• Active ASQ membership is desirable.
• Experience with document management systems and ERP platforms preferred.

Responsibilities

• Lead Quality, Regulatory, and Compliance Strategy
• Champion Mission, Risk Management, and Ethical Leadership
• Direct the Quality Management System (QMS)
• Drive Continuous Improvement and Performance Metrics
• Partner Across the Organization
• Develop People and Build High-Performing Teams
• Manage Resources and Budgets

Benefits

• Be part of a mission-driven company helping make people safer, healthier, and more productive.
• Know that your leadership directly impacts the safety and reliability of products used in laboratories, by healthcare providers, and by patients worldwide.
• Join a team that takes pride in craftsmanship, quality, and doing work that truly matters.
• Lead and develop high-performing teams within a collaborative environment that values continuous improvement and operational excellence.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 101-250 employees