Drucker Diagnostics · 14 hours ago
Quality Systems Manager
Philipsburg, PA
Full-time
Onsite
Senior Level
5+ years expDrucker Diagnostics is a company dedicated to enhancing health through accurate diagnostic information. The Quality Systems Manager will manage the company's Quality Management System, ensuring compliance with regulatory standards and fostering a proactive quality culture across the organization.
Health DiagnosticsIndustrial ManufacturingManufacturing
Responsibilities
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
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 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 in partnership with the Quality & Regulatory team
Support Management Review activities by preparing inputs, data analysis, and follow-up actions related to the QMS effectiveness
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
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
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
Support departmental resource planning and budget tracking
Help ensure staffing, tools, and systems align with quality and regulatory needs
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
Qualification
Required
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
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
Preferred
Experience with document management systems and ERP platforms preferred
Company
Drucker Diagnostics
Drucker Diagnostics is a manufacturer that supplies clinical laboratory equipment, centrifuges, analysers and accessories.
51-200 employees
Funding
Current Stage
Growth StageRecent News
EIN Presswire
2025-05-17
2025-04-23
Company data provided by crunchbase