Tru-D Quality Manager

DESCRIPTION

Driven by a commitment to research, quality, and service, PDI provides innovative products, educational resources, training, and support to prevent infection transmission and promote health and wellness. Encompassing three areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture, and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

POSITION PURPOSE

The purpose of the Quality Manager is to ensure Quality and Regulatory compliance in Tru-D's product development, manufacturing, distribution, and support processes. This role manages the implementation and maintenance of quality systems and processes; including, but not limited to, administration of the Electronic Quality Management system (QMS), ownership of interrelated Quality System Elements (QSEs) and processes, including Regulated Documents, Product Complaints, NC/CAPAs and associated training. This role plays a pivotal part in maintaining product quality and customer satisfaction.

ESSENTIAL FUNCTIONS AND BASIC DUTIES

• Maintain the Quality Systems and processes in accordance with Corporate Quality Objectives and applicable standards including FDA, EPA, and ISO.
• Implement and train on procedures for developing, changing, and maintaining disinfecting devices that can be used in healthcare settings. Ensure understanding and adherence to those procedures throughout the Tru-D organization.
• Maintain system documentation through regularly routing, reviewing, approving, distributing (internal/external) obsoleting, and archiving controlled documentation for all applicable areas of the QMS.
• Ensure key suppliers have adequate quality assurance and control measures in place and coordinate regular audits of their processes. Partner with key suppliers to ensure complaints, nonconformances and CAPA are resolved within established timeframes.
• Ensure adequate testing is being performed for sustaining engineering efforts.
• Ensure risk management plans are maintained for Tru-D products. Update plans through active management of complaints, non-conformances and CAPAs.
• Partner with Engineering and Suppliers to ensure that all safety standards are met, and products conform to all applicable safety standards.
• Partner with Marketing, Sales and Service teams to implement quality alerts and/or facilitate regulatory action.
• Ensure that all issues associated with regulated and registered products are properly managed, and data are provided to appropriate departments for internal use and for any Regulatory filings
• Create, maintain, and monitor monthly trending reports and metrics for management review and Continuous Improvement.
• Support regulatory inspections and audits by maintaining documentation and providing necessary information and assistance and eensure accurate, thorough, and on-time completion of all Agency and Third-Party Commitments.
• Other duties as assigned

PERFORMANCE MEASUREMENTS

• Attainment of established goals/metrics
• Regulatory and cGMP compliance
• Results of internal and external quality audits and inspections.
• Timeliness and accuracy of quality-related reports and documentation.

EDUCATION/CERTIFICATION

• Bachelor's degree in engineering, quality management, or a related field required; advanced degree preferred.

REQUIRED KNOWLEDGE

• Proficiency in quality management systems (e.g., ISO 13485, FDA QSR).
• Proficiency in ISO 14971 Risk Management for Medical Devices
• Experience with eQMS Systems (e.g., Master Control, Track Wise, Veeva, etc.) and eDMS Systems (e.g., SharePoint, Documentum, etc.)

EXPERIENCE REQUIRED

• 3-8 years of experience in quality management within the medical device industry.
• Demonstrated experience in managing quality system processes such as complaints handling.
• Experience auditing suppliers to internal or external Quality Standards
• Experience developing or managing risk management files.

SKILLS/ABILITIES

• Strong analytical and problem-solving skills; ability to systematically approach problems and develop logical and robust solutions.
• Strong written and verbal communication skills. Ability to present to all levels of the organization and externally to suppliers and Third Parties.
• Commitment to safety and quality.
• Highly motivated with the ability to work independently, multi-task, and collaborate effectively in a team environment.
• Have a sense of urgency with the ability to prioritize and use critical thinking to make timely decisions.
• Attention to detail and accuracy in documentation and reporting.
• Maintain confidentiality around sensitive documentation.
• Advanced Excel or Minitab skills for data analysis and reporting

WORKING CONDITIONS

• Work primarily in an office environment, with occasional visits to Tru-D or supplier's manufacturing facilities.
• May be required to travel occasionally for meetings, audits, inspections, or training purposes.
• Regular interaction with leadership, manufacturing staff and cross-functional teams.

SALARY RANGE

• $90,000 - $120,000 annually

BENEFITS

PDI is pleased to offer comprehensive and affordable benefits for our associates, which includes:

• Medical, behavioral & prescription drug coverage
• Health Savings Account (HSA)
• Dental
• Vision
• 401(k) savings plan with company match and profit sharing
• Basic and supplemental Life and AD&D insurance
• Flexible Spending Accounts (FSAs)
• Short & long-term disability
• Employee Assistance Program (EAP)
• Health Advocacy Program

PDI also offers many voluntary benefits such as: Legal services, critical illness, hospital indemnity, accident coverage, ID theft and fraud protection, pet insurance and employee discounts.

At PDI, we are also committed to helping our associates maintain a healthy and sustainable work/life balance and are proud to provide associates with paid time off programs including: sick & safe leave, vacation, company & floating holidays, paid parental leave, and depending on the position we also offer summer hours and flex place/flex time options.