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Director Of Quality
Posted on Dec. 17, 2024
- Limerick, United States of America
- 102562.0 - 129866.0 USD (yearly)
- Full Time

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- Leads the Quality Management System supporting manufacturing process development and operations while ensuring compliance with all regulatory requirements including US FDA, State, OSHA, and international medical device regulations based on ISO 13485 quality system requirements.
- Provides leadership for business process excellence and foster a culture founded upon Lean Management and Six Sigma principles and practices to drive customer value through continuous improvement.
- Serves as the business Management Representative to maintain a culture of compliance and excellence.
- Ensures the integration of risk management and risk analysis based on ISO 14971.
- Ensures the integration of risk based thinking throughout business processes to support decision-making.
- Works with the management team to establish strategic goals and objectives, organizational alignment, and a results-oriented work force.
- Provides leadership for workforce education and development within Quality.
- Develops, implements, communicates, and maintains quality planning supporting ISO 13485 quality system requirements and annual business goals and objectives.
- Oversees all Quality functions including documentation and training, customer feedback, nonconformance, CAPAs, supplier quality management, QC Inspection, and final product release.
- Manages and maintains the Company’s internal quality audit program and assess improvement initiatives resulting from all Quality Audits – internal and external.
- Ensures individual performance and business process performance meets established goals and objectives.
- Establishes, follows, and improves company procedures as needed to maintain compliance and meet business goals and objectives.
- Provides written and oral communication to help ensure an engaged and informed workforce and management team and keep them informed of results.
- Maintains a cooperative and motivational attitude with co-workers.
- Performs other tasks as requested by supervisor to meet business goals and objectives.
- Adheres to all Company policies, rules, procedures and housekeeping standards.
- Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies.
- Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role.
- Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties.
- Requires a bachelor’s degree (Engineering, Science, or Business preferred). A relevant post-graduate degree or qualification would be an advantage, but not essential.
- Minimum of 5 years of experience leading Quality Assurance / Quality Systems with experience in FDA and CE Notified Body inspections.
- At least 10 years of progressive experience is needed in QA/QC management in a manufacturing environment, preferably in the medical device industry.
- Lean and Six Sigma experience with a proven track record of business performance improvement and personnel development.
- Broad knowledge of manufacturing process control and validation.
- Knowledge of measurement systems and inspection process management.
- Understanding of Mil, ISO, and other applicable standards.
- Exposure to shop environment such as noise, dust, odors and fumes.
- Direct supervision of quality assurance employees in a manufacturing facility.
- Experience with manufacturing process quality, process controls plans and validation, CNC machining and finishing operations, and inspections systems is preferred.
- US FDA cGMP and ISO 13485 knowledge preferred. Manufacturing plant safety. Computer proficiency with MS Office and statistical analysis tools is required. Multi-discipline assurance background is desired with emphasis on problem solving and continuous improvement through work force engagement and development.
- ASQ certification or equivalent preferred (CMQ/OE, CSSBB, CQE, Lean Six Sigma). Must be able to make solid decisions that effectively support the business and company policies.
- Travel requirements are as needed.
- Presentation skills and ability to train personnel in Quality and Regulatory Compliance.
- Required to sit; climb or balance; and stoop, kneel, crouch or crawl
- Required to regularly lift and/or move up to 10 pounds, and occasionally lift and/or move up to 25 pounds
- Required to possess specific visons abilities, including: close vision, distance vision, color vision, peripheral vision, depth perception and capacity to adjust focus
- Passionate about Innovation: Improving patient care by delivering advanced technology to our customers is at the core of what we do. We are passionate ab our role in improving the lives of patients by continuously developing better solutions.
- Customer Focused: We listen to our customers’ needs and respond with a sense of urgency.
- Teamwork: Working together, anything is possible. We value every person on our team and treat each other with respect. We are accountable to one another and support each other. Together, we make each other stronger.
- Driven: We pursue our mission with energy and passion. We are nimble, results-oriented and decisive. We overcome obstacles that arise in our quest to deliver solutions that will improve the lives of our customers and patients.
Equal Employment Opportunity:
Other Duties:
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