Director, Quality Assurance & Regulatory Affairs

DESCRIPTION

At quip, we design and deliver delightful products and services that keep your mouth healthy. 

The Director of Quality Assurance and Regulatory Affairs is responsible for driving pre-market and post-market regulatory affairs activities and quality assurance / control programs of quip. This leadership position helps ensure global product integrity and operational compliance related to design, manufacturing, and sales for medical device and oral health products including supplier qualification,  product quality and reliability testing / engineering, obtaining regulatory approvals and establishing and maintaining quality control and assurance  standards with all external partners in keeping with business objectives. Additionally, this position is responsible for improving and driving a culture of total quality and compliance. 

The ideal candidate should have extensive experience with product reliability, manufacturing engineering, supplier evaluation and qualification,  compliance for consumer medical device hardware that is manufactured in ISO 13485 and GMP compliant facilities, and quality engineering. 

Base Salary: $150-$180k

This range represents anticipated base salary range for this position, in addition to competitive benefits and equity (as applicable). We carefully assess and consider several factors with each candidate, including location, role-related knowledge, experience and skills. Compensation may vary based on these considerations.

RESPONSIBILITIES

• Evolve  the Quality Engineering, Quality Assurance, and Compliance /  Regulatory functions to meet quip business objectives  and provide collaborative support to the cross functional team in the implementation and maintenance of the Quality Management System
• Support key product launches and new  business relationships by providing quality and regulatory expertise and guidance
• Reviews and interprets regulatory requirements as they relate to company products and processes, evaluates risk, and proposed solutions for mitigation
• Performs a lead role  in product development activities, including evaluating and advising personnel on manufacturing and regulatory impact through product lifecycle stages and change control activities
• Develop, execute and manage quality control, testing, reliability, and regulatory plans/strategies including regulatory activities (e.g. 510(k) submissions) for product development and product maintenance for existing/currently marketed products 
• Lead Continuous Improvements projects to improve customer satisfaction, reduce warranty / returns, and improve manufacturing efficiencies 
• Collaborate with sales, marketing, and legal on reviews and approvals of advertising and promotion materials and ensures customer compliance
• Manage post market activities, including customer complaints analysis/adverse event reporting, systems, clinical reports, etc. and develops / implements / verifies  action plans  to improve product quality that are appropriately effective
• Participate in the design, implementation, and maintenance of the Internal Audit Program
• Manage a timely and effective Corrective and Preventive Action (CAPA) system
• Provide guidance on PLM Software Design Controls implementation and maintenance to ensure product integrity 
• Provide Quality Management System (QMS) training and regulatory expertise, as needed
• Develop 3PL and supplier quality standards and implement systems to ensure compliance
• Partner closely with the executive leadership team to execute corporate strategy, goals and objectives

REQUIREMENTS

• 10+ years progressive experience in Engineering, Manufacturing, or Quality disciplines
• 5+ years of management experience including organization design, talent assessment, and people development
• Experience with consumer electronics, personal care products,  healthcare / medical devices, and/or  healthcare  software
• Experience in the following disciplines; product development, manufacturing, and sourcing
• Experience working in  start-up / dynamic growth environments
• Attention to detail
• Effective at conflict resolution and problem solving
• Excellent oral and written communication skills
• Willingness to be a “hands on” leader and actively assist with completion of the functional tasks needed to successfully transition the business
• Leads through subordinate managers; develops the functional/operational strategy and business plans to ensure alignment with the organizational transition plan
• Applies in-depth knowledge of own organization function or major operational segment as well as business and commercial expertise to differentiate the comp