Job Description
Job Description
Summary :
Responsible for leading and overseeing the quality assurance activities within the company's medical device manufacturing operations. This role involves ensuring compliance with regulatory standards, maintaining product quality, and driving continuous improvement initiatives to enhance manufacturing processes.
Maintains product and Company compliance with federal and state regulations, as well as rules and regulations specific to the medical device industry. Maintains compliance with FDA, QSR, and ISO 13485 requirements, including preparing for and leading successful audits.
Essential Duties and Responsibilities :
Quality Management System (QMS)
- Develop, implement, and maintain a robust and compliant quality management system in accordance with FDA regulations (21 CFR Part 820) and ISO 13485 standards
- Monitor and enforce adherence to quality policies, procedures, and work instructions across all manufacturing processes
Regulatory Compliance
Stay current with FDA regulations and international medical device regulations to ensure the company's practices align with industry requirementsProduct Quality Assurance
Ensure that manufactured medical devices meet or exceed quality standards, specifications, and performance requirementsImplement robust inspection and testing processes to detect and prevent defects, deviations, and non-conformitiesRisk Management
Lead risk management activities for the production, identifying potential risks associated with manufacturing processes and productsDevelop and execute risk mitigation strategies to minimize product-related risksSupplier Quality Management
Collaborate with the procurement team to assess and qualify suppliers based on quality and regulatory criteriaEstablish and maintain supplier quality agreements, conduct audits, and manage supplier corrective actionsInternal and External Audits
Plan and coordinate internal audits to assess the effectiveness of the QMS and manufacturing processesParticipate in audits and inspections by regulatory authorities, addressing findings and implementing corrective and preventive actions (CAPAs)Continuous Improvement
Drive a culture of continuous improvement by identifying process inefficiencies and opportunities for optimizationLead cross-functional teams to implement process enhancements and ensure sustained quality improvementDocument Control
Oversee the creation, review, and revision of manufacturing and quality-related documents, ensuring accuracy and complianceMaintain an organized and up-to-date document control systemEnsure accurate and comprehensive documentation of quality process, procedures, and production recordsTraining and Development
Provide training and guidance to manufacturing personnel on quality procedures, regulations, and best practicesFoster a sense of ownership for quality among all employeesMetrics and Reporting
Develop and present quality metrics and performance reports to senior management, highlighting key trends, achievements, and areas for improvementQualifications :
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Significant experience (typically 5 years) in quality assurance within medical device manufacturing, with a strong understanding of FDA regulations and ISO 13485 standardsProven experience in leading quality improvement initiatives and managing cross-functional teamsProficiency in risk management methodologies and root cause analysis techniquesExperience with internal and external audits, regulatory inspections, and interactions with regulatory agenciesDetail-oriented mindset with a commitment to maintaining accurate records and documentationProficiency in using quality management software and toolsStrong communication, leadership, and team-building skillsExcellent problem-solving skills and the ability to make sound decisions under pressureQuality management certification (e.g., CQM, CMQ / OE) preferredMust be fully trained and perform the following duties efficiently within IQMS :Corrective Actions
Document Control
Deviation
FMEA and Risk Assessment
APQP / PPQ
PPAP / PPQ
Education / Experience :
Bachelors of Science / Bachelors of Arts in science related field; OR 8 years of experience in medical QA / QA settingMinimum 8 years of management or supervision experienceMinimum 10 years of quality assurance experience in plastic injection moldingIQMS experience preferredExperience with Quality Improvement Tools and Techniques (i.e., Lean, Six Sigma, Statistical Process Control, and Failure Mode & Effects Analysis)Language Ability :
Ability to read, write, understand and follow instructions in the English language.
Effective oral and written communication in the English language.
Certificates and Licenses :
None
Supervisory Responsibilities :
Quality Assurance Department
Work Environment :
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Typical machine shop environment, requiring safety glasses. Employees are required to follow company policies and procedures (located in the company handbook) related to proper dress attire and safety.
Physical Demands :
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position involves sitting, standing and / or walking. It requires the use of typical office equipment such as a computer, copy machine, laptop and cell phone.
