BS in Quality Standards or related field, or 2+ years experience managing a quality program
Experience in the Medical Device or FDA-regulated industry is essential
Proven background in running ISO 9001:2015 standards
Hands-on inspection experience of incoming medical products
Experience with auditing organizations and presenting audit records
Strong verbal and written communication skills
Adept in data analysis and statistical methods
Excellent interpersonal skills
Detail-oriented and diligent
Proficiency in Microsoft Office (Excel, Word, PowerPoint)
Responsibilities
Implement and execute product inspection and evaluation methods
Prepare reports on inspections and receiving processes
Report quality standard issues to upper management
Supervise staff to uphold quality standards
Maintain a Quality Management System in line with industry standards
Conduct and manage company training and qualification programs
Monitor and communicate on product recalls with upper management and customers
Maintain comprehensive product photo library for warehouse
Benefits
Opportunity to work in a critical area of quality management in the Medical Device industry
Engagement with various department heads to shape quality standards
Involvement in maintaining ISO Certification, a prestigious industry standard
Access to continuous training and professional development programs
Chance to lead audits and interact with certification authorities
Full Job Description
Job Description
We are seeking Quality Manager to assist the various department heads in formulating quality standards and regulations for employees and products. They must analyze data gathered and plan accordingly to improve quality output. They will be accountable for identifying mistakes and quality related processes from purchasing, receiving, storing and shipping, that are crucial to maintaining ISO Certification.
Duties and Responsibilities
The Quality Manager is responsible for implementing and executing inspection and evaluation methods to ensure products adhere closely to company standards
Prepare reports by collecting data on inspections or other aspects of the receiving process
Reporting to upper management regarding quality standard issues
Work according to deadlines while delivering outstanding service within the industry's needs
Supervising staff and ensuring qualitative standards are maintained
Work with a Quality Management System keeping up to date on current industry standards and ensuring company maintains all standards.
Conduct and manage company training and qualification program.
Monitor and maintain product recall database. Communicate recalls to upper management and interface with customers on product recalls.
Maintain a photo library of all products brought into the warehouse for sale.
Present a Quality Management system for multiple audits throughout the year by customers and certification authorities.
Qualifications
BS in Quality Standards or other related field of study or 2 years plus experience in running a quality program.
Experience in Medical Device or other FDA-regulated industry a MUST
Previous experience running an ISO 9001:2015 International Standards
Hands-on experience with the inspection of incoming medical products
Confidence and past experience with both auditing organizations and presenting records for audit by outside organizations
