Director Of Quality Jobs

We are a leading medical device company dedicated to improving healthcare outcomes and patient well-being. Our innovative and high-quality Collagen devices/components are trusted by healthcare professionals across the Nation and have been extremely effective in treating Chronic wounds. As we continue to grow and expand, we are seeking a skilled and experienced Quality Director to ensure the highest standards of quality throughout our organization.

Job Summary:

In this role, the Director of Quality will lead and manage all Quality Management System activities in support of the development and manufacture of tissue and polymer based medical devices and components.

Responsibilities (Essential Duties and Responsibilities):

• Lead, develop, and implement new strategies, processes, and policies as it relates to Quality Management System effectiveness, Good Manufacturing Practice requirements, complete customer satisfaction, and financially-sound business practices.

• Drive the establishment, communication, achievement, and maintenance of corporate quality objectives.

• Establish and implement quality plans and systems for new products to ensure ongoing compliance and customer satisfaction.

• Manage the process validation processes for all production activities.

• Manage the timely execution of QMS required activities, such as CAPAs, nonconformance's, and supplier audits.

• Manage the supplier quality program, including supplier qualification, performance monitoring, audits, and corrective actions.

• Monitor the effectiveness of the Quality Management System through key performance indicators.

• Develop and implement Quality Management System improvements based on key performance indicators and changes to government regulations or industry standards.

• Serve as the Management Representative for Viscus Biologics’ ISO 13485 Quality Management System certification activities.

• Manage periodic Management Review activities in accordance with Quality Management System requirements.

• Review, analyze, and apply risk management techniques throughout all Quality Management System processes, procedures, and activities.

• Lead the Quality activities for design services work in accordance with defined deliverable targets, including supplier qualifications, process validations, risk assessments, and quality plans.

• Initiate and maintain quality agreements with customers and suppliers as required.

• Support regulatory product submissions and maintenance through testing and documentation.

• Revie technical reports, making data-based recommendations for the products and processes.

• ·Manage documents, records, and the change review process for existing medical device products and new products under development.

• Review Design History Files and Technical Files for conformance to applicable requirements. Manage the maintenance of Design History Files and Technical Files for continued conformance.

• Manage customer complaints, complaint investigations, and any customer communications related to the complaint.

• Manage the environmental monitoring program and activities associated with the validation, execution, and monitoring of terminal sterilization of medical devices.

Minimum Required Qualifications (Knowledge, Skills, and Abilities):

• Bachelor’s degree in a field of science.

• 5+ years of experience in a regulated industry (preferably in the medical device field).

• Strong familiarity with 21 CFR 820 Quality System Regulations and with ISO 13485-2016.

• Ability to take initiative, operate independently, and thrive in a fast-paced environment.

• A strong sense of urgency and attention to detail, excellent organization, communication, and follow-up skills will be attributes of the ideal candidate along with the ability to self-direct and problem-solve.

• Strong interpersonal skills including the ability to build strong relationships.

• The ideal candidate will be able to communicate effectively across all levels of the organization as well as with external customers and suppliers. They will have strong attention to detail and be able to manage multiple competing priorities.

• Proficient in the use of personal computers, including the use of Microsoft Outlook, Microsoft Word, and Microsoft Excel.

Preferred Qualifications (Knowledge, Skills, and Abilities):

• Familiarity with the Medical Device Single Audit Program (MDSAP).

• Experience managing work in certified cleanroom environments.

• Experience in internal auditing, and supporting external audits and agency inspections.

• Certification in quality auditing, engineering, inspecting, improvement, Good Manufacturing Practices, or Six Sigma.

• Strong analytical and advanced statistical skills, including the ability to perform such analyses using computerized tools.

Language Skills:

• Candidate must have the ability to proficiently read, analyze and interpret general business periodicals, professional journals, technical procedures, and government regulations written in the English language. Must also be able to effectively present information and respond to questions from groups of managers, clients, customers, and the general public in the English language.

Work Environment:

• The individual will split time between a typical office environment and the manufacturing area, which consists of a mix of cleanroom and lab-style manufacturing spaces. When in the cleanroom, the individual will be expected to wear designated gowning and follow standard anti-contamination practices.

• All areas are environmentally controlled.

• Potential exposure to hazardous chemicals.

Physical Demands:

• The individual will be expected to perform standard office work, which involves writing, typing, filing, and other work performed at a desk or in a normal office environment.

• Prolonged periods of sitting at a desk and working on a computer.

• Moves equipment weighing up to 30 pounds on occasion.

• Must be able to wear a respirator as needed.

Travel:

• · Minimal travel is expected