Quality Management System Specialist - 146537

Our client is an established biotechnology company specializing in developing products for advanced wound care. They are seeking a Quality Management System Specialist to join their team!Salary/Hourly Rate$120,000 – $135,000Position OverviewThe Quality Management System Specialist will develop, implement, and manage a Quality Management System (QMS) compliant with 21 CFR 820. The Quality Management System Specialist will support various administrative, documentation, customer support, and manufacturing activities. The ideal candidate will have excellent communication, organizational, and interpersonal skills, with experience in CRM systems and working with external vendors and manufacturers. This role will likely come out of a Medical Device company, but could also have closely related pharmaceutical or biotech experience.Responsibilities Of The Quality Management System Specialist• Create, implement, and manage the company’s Quality Management System (QMS) compliant with 21 CFR 820 for Class II medical devices• Serve as the primary contact for QMS regulatory requirements and ensure all devices meet internal, industry, and regulatory standards• Work with the R&D team to fulfill all design control requirements• Extend the QMS to vendors and efficiently monitor their production, storage, and distribution operations for compliance with company specifications• Establish and conduct vendor audits, reviewing findings, and implementing necessary actions• Develop and manage processes for non-conforming products, CAPA, change control, and complaints• Manage quality agreements with vendors and review findings with management• Oversee the Customer Relationship Management (CRM) system to enhance customer interactions, streamline processes, build relationships, increase sales, and improve customer service• Support product manufacturing by working with manufacturers and suppliers, answering product-related questions, and completing relevant documentation• Respond to customer complaints and inquiries while gathering necessary data for resolutionQualifications For The Quality Management System Specialist• 5 to 10 years of quality experience and proven track record of setting up a Quality Management System (QMS) from scratch or significantly revamping an existing one• Excellent communication, organizational, and interpersonal skills. Experience with CRM systems and working with outside vendors/manufacturers is highly desirable• Must be flexible to handle various administrative, documentation, customer support, and manufacturing support tasksEducation Requirements• Bachelor’s degree in Business, Science, Engineering, or a related field is requiredBenefits• Medical, Dental, and Vision• 401kAs a woman-owned firm, we value diversity. We are an equal opportunity and affirmative action employer and will consider all applications without regard to race, sex (including gender, pregnancy, sexual orientation and gender identity), age, color, religion or creed, national origin or ancestry, veteran status, disability (physical or mental), genetic information, citizenship or any other characteristic protected by law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Candidates who apply for roles through the Atrium website will be added to our candidate pool and may be considered for additional roles of a similar title. Please contact us to request an accommodation.EOE/M/F/D/V/SOPosition ID: 146537