Senior Director, Quality Assurance

Position Title: Senior Director, Quality Assurance                        Job Location: Fremont, HQ

Department: Quality Assurance                                                  Worker Category: Full-Time /Exempt

Industry: Neurovascular / Medical Devices

About Q’Apel: 

At Q’Apel, we are passionate about revolutionizing neurovascular access. In the simplest sense, we’re a company that creates solutions. We design novel access device technology for vascular interventions and unmet clinical needs. Successful Q’Apel team members step up to the plate and work together to achieve our goals every single day. We are a fast-paced, high-growth company with a startup philosophy which requires an all-hands-on-deck attitude, taking on all changes with excitement and a great attitude.

Who We Want:

As a pivotal member of the leadership team, the Senior Director of Quality Assurance will be responsible for the day-to-day management of quality operations including assuring all areas operate in support of the company and department objectives and in compliance with applicable regulations and standards.   This role includes the oversight of incoming inspection, manufacturing QC, sterilization, product acceptance testing and release, document control, equipment management, supplier management, manufacturing process verifications/ validations, as well as associated nonconformance control, equipment impact assessments, supplier corrective actions, and CAPAs.  

What You’ll Work On:

• Facilitate, maintain, and implement Best in Class Quality Assurance Management improvements to quality operations while maintaining compliance with applicable Quality System Regulations, Medical Device Regulations, and ISO standards (including, but not limited to 13485, 14971, 11135, and EU MDR) and in consideration to the needs of a small to mid-size business.  
• Take a leadership role in achieving strategic quality initiatives including the establishment of project aspects such as scope, schedule, resources, risks, deliverables/ milestones according to released Quality Plans, and leadership to drive towards meeting the objectives.  
• Provide leadership, direction, and mentorship to quality personnel; including but not limited to inspectors, engineers, specialists, consultants, and cross-functional areas as needed to ensure compliance with applicable federal and state regulations, international standards, and the company’s Quality Policy.  
• Assure timely lot release of commercial products including sterilization processing, biological testing, quality inspections, and testing, and review of lot history records. 
• Responsible for the collection, analysis, and actions taken for Quality/ business metrics and metrics to be provided and reviewed with cross-functional management through quality reports and management reviews.  
• Support, participate, and defend operational quality management system areas during audits as the subject expert.  
• Meet completion dates for assigned projects, internal and external audit observations related to operations quality, CAPA plans, procedural updates, and other duties as assigned.  
• Work interactively with cross-functional teams within a small/ medium company environment to facilitate results and accomplishments.  
• Continually identify and implement improvements and changes to current operational processes using scalable quality tools and solutions to meet Q’Apel’s current and future needs.        Improvements may be identified through observation of daily operations, gap analysis, audits, and departmental reviews.  
• Ensure operational quality assurance goals are aligned with department and company objectives.        Develop or provide input to SMART goals, development plans, performance evaluations, and other personnel reviews for subordinates as required.  
• Leader and influencer of others by motivating, training, and inspiring personnel to achieve high-quality products and a culture that supports Q’Apel’s Quality Policy and compliance with our Quality Management System. 
• Participate in industry and other professional networks to ensure awareness of industry standards, trends, state-of-the-art, and best practices in order to strengthen Quality System knowledge.  
• Other duties as assigned.

What You Bring:

Education:

• BS/BA degree in biology, engineering, or equivalent scientific discipline.
• Master’s degree in biology, engineering, or equivalent scientific discipline preferred.

Experience & Skills:

• Minimum of 15 years’ experience in a principal quality engineering or quality leadership role, or related experience in the medical device industry. Neurovascular/ vascular device experience preferred. 
• Minimum of 10 years experience managing Quality Inspectors and other non-exempt and exempt employees.
• Strong knowledge of Quality System Regulations, ISO 13485:2016, Medical Device Regulations, ISO 14971, sterilization standards, and validations, bioburden, and endotoxin testing, and Controlled Environment Room (CER) commissioning and monitoring. US Class I, II, and ISO Class III device knowledge preferred.
• Strong skills in processing CAPAs and in the implementation of CAPA process linkages to other quality system elements.  
• Experience with sterilization validations, biological testing for lot release, environmental monitoring, biocompatibility testing, and quality system assessments.
• Exceptional written and verbal communication skills to convey detail and analytical problem-solving solutions.
• Strong understanding of identification and traceability requirements throughout all stages of the manufacturing processes.  
• Strong working knowledge of engineering drawings (GD&T preferred).
• Experience with statistical techniques (sampling and SPC), DOE, Six Sigma, and working knowledge of statistical software like Minitab.
• Versed in business software including word-processing, spreadsheets, flowcharting, databases, and project management.
• Proven success with project management and implementation of quality system improvements. 
• Strong delegation skills with the ability to influence across multiple levels within the organization to drive project quality and compliance activities.  

Our salary ranges are calculated by role and level. Your position within that range will be determined by your job-related knowledge, skills, experience, relevant education, and training/certifications. In addition to those factors, we also examine internal equity as well as consider the current market rate, and the title may be assessed one level lower or higher accordingly. After you join the company your performance, contributions, and results along with business and organizational needs will affect your base salary. The base salary range for this full-time position is between $220,000 to $260,000 equity benefits.

This document contains confidential, proprietary information of Q’Apel Medical, Inc. It may not be copied or reproduced without prior written permission from Q’Apel Medical, Inc.