Bachelor's Degree in Engineering, Chemistry, Biology, or related field.
5-8 years of quality assurance experience in regulated environments.
1-3 years of experience managing a quality team.
Certifications like CQE, CQA, CMQ/OE, Lean, or Six Sigma are a plus.
Preferred experience in chemical mixing, liquid formulation, or filling operations.
Strong interpersonal skills and leadership capabilities.
Proficiency in root cause analysis and effective corrective actions.
Responsibilities
Serve as the Quality Management Representative (QMR) for the facility.
Lead and train quality assurance personnel, managing performance and development.
Conduct thorough investigations of complaints and non-conformities in a timely manner.
Champion continuous improvement and standard work initiatives.
Oversee the Corrective Action Program (CAPA) and chair the Corrective Action Board (CAB).
Manage calibration activities for Inspection, Measure, and Test Equipment (IM&TE).
Support product integrations and new product development efforts.
Benefits
Opportunities for leadership and professional development.
Collaborative and team-oriented work environment.
Engagement with both domestic and international quality standards.
Involvement in strategic quality initiatives and continuous improvement efforts.
Full Job Description
Summary
The Quality Manager serves as the designated Quality Management Representative (QMR) for all aspects of the Quality System within our chemical mixing / medical device manufacturing operation. This role has responsibility for planning, directing, and executing activities of our quality assurance, quality engineering, supplier quality, and quality control programs including strategic leadership for related activities, assuring the development, application, and maintenance of quality standards for processes, materials, and products. This role is also responsible for the achievement of quality objectives and operational targets, corrective action, and the implementation and maintenance of an overall effective and compliant Quality System.
In This Position, You Will Have the Opportunity To:
Serve as the Quality Management Representative (QMR) for the manufacturing facility, including hosting third party audits and inspections, organizing and conducting periodic Management Reviews of the Quality System
Carry out leadership responsibilities in accordance with the organization's policies and applicable laws which includes interviewing, hiring, developing and training employees; planning, assigning, and directing work; appraising performance; rewarding and coaching employees; addressing complaints and resolving problems
Ensure all required investigations (i.e. complaints, NCs) are robust, thorough, and completed in a timely manner
Champion and lead continuous improvement, VIP, and standard work efforts
Chair the site's Corrective Action Board (CAB) and drive the CAPA program by ensuring opportunities are well documented, timelines are adhered to and status is reported to management on a routine basis
Oversee activities associated with calibration of Inspection, Measure, and Test Equipment (IM&TE) including standards, recall, review/approval of records, and out of tolerance investigations
Lead, maintain and create efficiencies in the Quality Management System to fulfill both domestic and international quality system requirements (e.g. FDA's QMSR, ISO 13485, and other international standards)
Host FDA/ISO and other regulatory agencies or customers for audits
Support product integrations associated with acquisitions and new product development
Ensure the effective maintenance of Device History Records, and other quality documents
Manage the internal audit program including training internal auditors, creating and maintaining internal audit schedules, assuring internal audits are performed and completed according to approved schedule
Monitor the health and well-being of the QMS through quality trending, analytics and established KPIs
What You Need to Succeed in This Position
Bachelor's Degree in Engineering or a related technical discipline such as, Chemistry or Biology.
A minimum of 5-8 years of quality assurance experience in a medical device, pharmaceutical, or regulated manufacturing environment.
A minimum of 1-3 years' experience managing quality team members.
Industry or discipline specific certification a plus (CQE, CQA, CMQ/OE, Lean, Six Sigma, etc)
Experience in chemical mixing, liquid formulation, or filling operations preferred.
Displays developed interpersonal skills: leadership, team orientation, ability to communicate at all levels
Ability to make effective decisions and maintain effectiveness under changing circumstances and priorities
Teamwork, communication, positive attitude required to support the manufacturing environment
Extensive experience in problem solving - able to perform root cause analysis and implement effective corrective actions
Able to effectively manage and complete multiple projects simultaneously
Excellent computer skills including but not limited to Microsoft Office Suite
Knowledge of quality systems including the quality manual, quality policy and applicable procedures and work instructions
Ability to support the establishment, implementation, and maintenance of the quality system in accordance to FDA Quality Management System Regulation, ISO 13485, and European Union Medical Device Directives.
