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Drucker Diagnostics · 6 days ago

Director of Quality & Regulatory

Philipsburg, PA

Full-time

Onsite

Lead/Staff, Director/Executive

5+ years exp

Drucker Diagnostics is a company dedicated to improving health through accurate diagnostic testing. As the Director of Quality & Regulatory, you will lead the Quality Management System and Regulatory strategy to ensure product safety and compliance, while fostering a culture of continuous improvement across the organization.

Health DiagnosticsIndustrial ManufacturingManufacturing

Diversity & Inclusion

Responsibilities

Lead Quality, Regulatory, and Compliance Strategy

Create 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

Oversee ISO 13485 certification activities and all internal, customer, and regulatory audits

Develop and execute regulatory strategies to ensure compliance with FDA, ISO, and applicable regulations

Serve as the organizational leader for Quality and Regulatory matters

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

Lead risk management activities across all stages of design, manufacturing, and product lifecycle

Proactively identify regulatory, quality, and operational risks and lead mitigation strategies

Direct the Quality Management System (QMS)

Direct all Quality Control and Quality Assurance functions across the organization

Administer and continuously improve document control and configuration management systems

Review, approve, and oversee investigations, nonconformances, and CAPA activities

Conduct annual Management Reviews to ensure the adequacy, suitability, and effectiveness of the QMS

Drive Continuous Improvement and Performance Metrics

Establish, analyze, and report Quality KPIs to internal leadership and external stakeholders as required

Lead initiatives to reduce out-of-box failures, customer complaints, and quality-related losses

Implement quality improvement methodologies to increase productivity, consistency, and customer satisfaction

Develop and implement 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

Lead quality involvement in the build-out and operation of GMP manufacturing capabilities

Develop People and Build High-Performing Teams

Lead, coach, and develop Quality and Regulatory team members

Establish clear departmental goals aligned with corporate strategies

Maintain open communication through regular one-on-one and team meetings

Ensure a compliant, effective training program is maintained for all employees

Manage Resources and Budgets

Manage departmental budgets and resource planning

Align staffing, tools, and systems to support quality and regulatory objectives

Supervisory Responsibilities

This position directly supervises Quality and Regulatory team members and carries out supervisory responsibilities in accordance with company policies and applicable laws, including hiring, training, performance management, coaching, and employee development

Qualification

ISO 13485FDA regulationsQuality Management SystemContinuous improvementQuality AssuranceRegulatory complianceTeam developmentDocument managementComputer skillsMS Office SuiteAdobe AcrobatLeadershipInterpersonal skillsOrganizational skillsProblem-solvingCommunication skillsCustomer focus

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

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

Alternate education and experience considered based on the individual candidate

Strong computer skills required for documentation and training

Proficiency in MS Office Suite (PowerPoint, Word, Excel, Outlook, etc.)

Adobe Acrobat proficiency required

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

Occasional local travel during the business day, mostly between facilities