Quality Manager at Drucker Diagnostics

Philipsburg, Pennsylvania, United States -

Full Time

Start Date

Immediate

Expiry Date

25 Apr, 26

Salary

0.0

Posted On

25 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, ISO 13485, FDA Regulations, Continuous Improvement, Risk Management, Leadership, Documentation, Problem Solving, Collaboration, Customer Focus, Training, Auditing, Data Analysis, Manufacturing, Engineering, Regulatory Compliance

Industry

Medical Device

Description

Who We Are At Drucker Diagnostics, we know that making people safer, healthier, and more productive 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, build, and support 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 impacts patient outcomes. The Quality & 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 difference building something truly remarkable, join us. Your Mission As the Quality Manager, you will work closely with the Director of Quality & Regulatory and the members of the Quality & Regulatory Team, managing the company's Quality Management System. 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. What You'll Do: Essential Duties and Responsibilities Support Quality, Regulatory, and Compliance Strategy Support a strong culture of compliance related to Safety, Environmental, and Quality standards. Ensure all processes, procedures, and outputs meet ISO 13485, FDA, and internal quality standards. Coordinate and support ISO 13485 certification activities and all internal, customer, and regulatory audits. Partner with the Director of Quality & Regulatory to support regulatory strategies and ongoing compliance efforts Champion Mission, Risk Management, and Ethical Leadership Demonstrate a strong commitment to the organization’s Mission, Vision, and Core Values. Support a company culture dedicated to safety, continuous improvement, employee growth, and well-being. Participate in and support risk management activities across all stages of design, manufacturing, and product lifecycle. Proactively identify regulatory, quality, and operational risks and lead mitigation strategies. Manage and Maintain the Quality Management System Manage day-to-day Quality Control and Quality Assurance activities in alignment with established QMS requirements. Administer and continuously improve document control and configuration management systems. Review, support, and coordinate investigations, nonconformances, and CAPA with your team. Support Management Review activities by preparing inputs, data analysis, and follow-up actions. Drive Continuous Improvement and Performance Metrics Track, analyze, and report Quality KPIs to support leadership decision-making and regulatory requirements. Support initiatives to reduce out-of-box failures, customer complaints, and quality-related losses. Apply quality improvement tools and methodologies to increase productivity, consistency, and customer satisfaction. Assist in the development and implementation of new quality standards, including manual and automated test procedures. Partner Across the Organization Collaborate with Engineering, Manufacturing, Supply Chain, and Operations to support product development, process improvements, and new product introductions. Support reliability engineering, failure analysis, supplier quality, quality engineering, and auditing activities. Participate in quality support for GMP manufacturing capabilities as required. Develop People and Support Team Effectiveness Support the development and day-to-day management of Quality & Regulatory team members. Assist with setting clear departmental goals aligned with organizational priorities. Maintain open communication through regular one-on-one and team meetings. Support a compliant, effective training program for all employees. Manage Resources and Planning Support departmental resource planning and budget tracking. Help ensure staffing, tools, and systems align with quality and regulatory needs. Supervisory Responsibilities This position may provide day-to-day work direction, coaching, and support to Quality and Regulatory team members and may participate in hiring, training, performance management, and employee development activities in accordance with company policies and applicable laws. What You'll Bring Required Qualifications: 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. Active ASQ membership is desirable. Excellent written, verbal, and presentation communication skills. Ability to present information to all levels of employees and partners. Desired Education and Experience: 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. Alternate education and experience considered based on the individual candidate Computer Skills: Strong computer skills required for documentation and training. Proficiency in MS Office Suite (PowerPoint, Word, Excel, Outlook, etc.) Experience with document management systems and ERP platforms preferred. Adobe Acrobat proficiency required. Physical and Work Environment Requirements: Office and Manufacturing Environment with a strong focus on safety and quality. PPE is required in designated areas. Combination of sitting, standing, and moving throughout the facility during the workday Ability to frequently lift or move materials up to 25 pounds. Travel Requirements: Occasional local travel during the business day, mostly between facilities. Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off (Vacation, Sick & Public Holidays) Family Leave (Maternity, Paternity) Short Term & Long Term Disability Training & Development At Drucker Diagnostics, we know that behind every great product is a great person. We would be honored to have you join our team and our vision for building something truly remarkable that will long outlast us!

Responsibilities

The Quality Manager will manage the company's Quality Management System and ensure compliance with regulatory and customer requirements. This role involves supporting a proactive quality culture and collaborating with cross-functional teams to enhance product quality and safety.