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Vice President of Quality

Company: Baebies Inc.
Location: Durham
Posted on: May 14, 2022

Job Description:

Baebies Inc. () is a well-funded growth-stage company that develops and commercializes products for testing in the newborn screening and pediatric diagnostic markets. The company's existing FDA-cleared SEEKER product is sought by US public health labs, where the majority of biochemical newborn screening occurs. The company has shipped over 12 million SEEKER tests to date. Baebies' second diagnostic platform, FINDER, is CE Marked and 510(k) pending and is poised for explosive growth in the near term. Job Summary: The VP of Quality plans, organizes, directs, and controls the activities of the company related to quality systems, document control, and product test, inspection, and lot release. This executive defines expectations and objectives for quality throughout the organization and provides measurement, monitoring and reporting demonstrating achievement of objectives and compliance of the quality system with applicable standards. Duties & Responsibilities: - Develops and implements quality system procedures to ensure compliance to applicable industry standards and regulations such as Quality System Regulation 21 CFR Part 820, ISO 13485, and the European Union's In Vitro Diagnostic Regulation. May include other international regulations as applicable. Understands that while external quality requirements are important, they are not necessarily sufficient; driven to improve quality each day. - Supports compliance audits/inspections by certification bodies and regulatory authorities. Trains subject matter experts and other personnel in dealing with certification/regulatory authorities. - Manages the internal auditing program to ensure continued compliance and report compliance status to the executive management team. Oversees management of equipment records and ensures all equipment is on proper maintenance and calibration schedule. - Manages the Non-Conforming Material, Deviation, and CAPA Systems. Serves as Management Representative for Quality and Person Responsible for Regulatory Compliance (PRRC) for Quality-related items. - Manages quality engineers & technicians supporting research & development, design transfer, and commercial operations. - Manages the QC Test Lab ensuring compliance with regulatory requirements through quality system procedures while performing product testing to support design transfer, production, and stability monitoring schedules. - Manages document control ensuring compliance with regulatory requirements through quality system procedures while supporting timely release and revision of controlled documentation, standards maintenance, and training program. - As a member of the executive team actively contributes to and participates in key company decisions. Works hard to develop and maintain a cohesive executive team. Is totally bought in to achieve the mission and to fulfill Baebies' outrageous growth expectations. - Collaborates with product development teams to successfully transition new products to operations. - Leads efforts to solve problems, address customer complaints, and improve not just product quality but the quality of the customer experience. - Recruits, selects, on-boards, trains and retains qualified personnel in all positions in the quality function. Always working to make the team function and perform better. - Monitors supplier quality. Understands how important the supplier team is to delivery, quality, and product cost and is committed to continuous improvement of supplied materials. - Develops, modifies, improves and reports company-wide metrics as a part of an ongoing performance improvement program. - Develops, reviews, endorses and complies with functional budgets. - Collaborates with other departments in carrying out all responsibilities. Successfully builds relationships across functions at multiple levels within operations. .

Education & Experience Required: - Bachelor' Degree or greater in a scientific field - 10+ years' experience in manufacturing environment, 5+ years in a senior quality management position. - Expert knowledge of medical device regulations, standards, current industry practices, and strong experience with interpretation and application. Experience with hardware/software medical devices. - Strong problem solving, communication skills and project management skills required - Experience with all phases of the product development lifecycle, including concept, design, implementation, verification and validation activities necessary for product commercialization. Compensation & BenefitsBaebies offers a dynamic and welcoming work environment surrounded by intelligent, driven, and creative people. Guided by the vision that everyone deserves a healthy start, our team is devoted to our customers and to advancing technology in early disease detection and comprehensive diagnosis. At Baebies, we look for people who are innovative, dedicated to our mission, and constantly striving to improve the status quo. In addition to competitive, market-driven compensation, Baebies provides a comprehensive employee benefits package including: - 100% employee premiums for Medical & Vision coverage - 100% employee and family premiums for Dental coverage - 401K Matching - Stock Options - 4 Weeks PTO - 14 Paid Holidays per year - Paid Employee Life Insurance - Onsite free gym membership & classes - . . . Much more! Baebies, Inc. is an equal opportunity employer. PI175114503

Keywords: Baebies Inc., Durham , Vice President of Quality, Executive , Durham, North Carolina

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