Director of Quality & Regulatory 
ON-SITE Role. Philipsburg, PA

Who We Are

• 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.

• 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 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.

• 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.

• 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.

• 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 departmental budgets and resource planning.
• Align staffing, tools, and systems to support quality and regulatory objectives.

• 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.

• 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.
• 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.

• 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.

• 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.