POSITION SUMMARY

The Quality Manager will be responsible for building, managing, and leading the quality assurance department staff, working in partnership with sales, engineering, procurement, and operations, to ensure the highest possible quality products. This role will develop and implement effective, robust quality management system processes and methods in alignment with the FDA QSR and ISO requirements, and utilize metrics to continually improve quality processes and efficiency.

Responsibilities:

• Develop, deploy, and execute Quality Policies, Quality Objectives, and Quality Plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements
• Support, develop, implement, and maintain all QMS processes and procedures, including but not limited to; Complaint Handling, Design and Development, Change Control, Risk Management, Corrective and Preventive Action, Internal Audits, Supplier Quality, Process Control, Document Control and Identification and Traceability
• Establish and lead a high-performing team of Quality Engineers, Quality Supervisor and Document Control, providing mentorship and coaching to staff as needed
• Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines
• Responsible for implementation, support, validation of computer system QMS modules
• Monitor and assess the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement, ensuring continued certification to applicable standards
• Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate
• Collect, analyze, and present data on the QMS during Management Review Meetings. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause – corrective action
• Creating management level presentations and reports
• Ensure qualification, selection and monitoring of suppliers and any related quality issues
• Support a culture of Operational Excellence, inclusive of lean and six sigma principles
• Act as the Deputy Management Representative should need arise
• Act as a representative for external audits; customers, regulatory authorities, and registration agencies
• Support and comply with the company Quality System, ISO, and medical device requirements
• Ensure business systems are implemented, maintained, and functioning properly

Qualifications:

• Bachelor’s degree in Engineering, Sciences, Quality, or relevant experience
• 8 years of experience in Quality Assurance or related management experience in manufacturing engineering or operations discipline, in a regulated field
• 5 years of leadership experience
• Experience with ISO 13485, ISO 14971 and GMP
• Auditing, writing procedures, supplier quality assurance, verification & validation
• In depth knowledge of FDA Quality System Regulation, Good Manufacturing Practices, 21 CFR Part 820 and cleanroom standards, or other relevant regulated requirements
• Excellent working knowledge of quality tools, variable and attribute sampling plans, root cause analysis, DOE, Statistics, Lean Manufacturing, and Six Sigma – an asset
• Demonstrated leadership skills with the ability to build and maintain an efficient, effective organization with a team focused on continual improvement
• Ability to prioritize, plan, and evaluate deliverables to established strategic goals and timelines
• Ability to consistently achieve short and long-term business results
• Ability to follow through on commitments and holds team members accountable
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Ability to work in a manufacturing environment
• Attention to detail

PREFERRED REQUIREMENTS

• Continuing Education; including participation in local chapters, associations, and/or organizations

• Develop, deploy, and execute Quality Policies, Quality Objectives, and Quality Plans that support the corporate strategic business goals and conform to customer, internal, ISO 9001:2015 and EN ISO 13485:2016, regulatory and legal requirements
• Support, develop, implement, and maintain all QMS processes and procedures, including but not limited to; Complaint Handling, Design and Development, Change Control, Risk Management, Corrective and Preventive Action, Internal Audits, Supplier Quality, Process Control, Document Control and Identification and Traceability
• Establish and lead a high-performing team of Quality Engineers, Quality Supervisor and Document Control, providing mentorship and coaching to staff as needed
• Ensure effective coordination of investigations, root cause analysis, risk assessments, field actions and implementation of change control and corrective and preventive actions to the adhered timelines
• Responsible for implementation, support, validation of computer system QMS modules
• Monitor and assess the QMS processes for compliance, effectiveness, continued alignment with applicable regulatory and statutory requirements, and opportunities for improvement, ensuring continued certification to applicable standards
• Maintain Quality System Dashboards, Scorecards / Key Performance Indicators for the quality system processes. Review and monitor trends, communicating issues to department management. Contribute to and assist in providing quality system training as appropriate
• Collect, analyze, and present data on the QMS during Management Review Meetings. Drive process implementation including quality control plans, validation, qualifications (IQ, OQ, PQ) and root cause – corrective action
• Creating management level presentations and reports
• Ensure qualification, selection and monitoring of suppliers and any related quality issues
• Support a culture of Operational Excellence, inclusive of lean and six sigma principles
• Act as the Deputy Management Representative should need arise
• Act as a representative for external audits; customers, regulatory authorities, and registration agencies
• Support and comply with the company Quality System, ISO, and medical device requirements
• Ensure business systems are implemented, maintained, and functioning properl