Principal Quality Systems Specialist

Position Title: Principal Quality Systems Specialist                            Job Location: Fremont, HQ

Department: Quality Assurance                                                            Worker Category: Full-Time 

Job Class: Professional                                                                           FLSA: Exempt

Industry: Neurovascular/Life Sciences/Medical Devices                 Job Function: Quality

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 Quality team, the Principal Quality Systems Engineer will be responsible for ensuring that the company's Quality System is compliant to all applicable standards.  This role includes but not limited to  the oversight of all Quality Systems activities to include but not limited to CAPA Management, Internal Audit Management, Document Control, and Supplier Quality.

What You’ll Work On:

• Facilitate, maintain and implement Best in Class Quality 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.  
• Support all functions during external audits.
• Coordinate and execute to Internal Audit schedule and any necessary remediation.
• Lead the Post Market Surveillance process and ensure timely execution of all Post Market Surveillance related activities. 
• Meet completion dates for assigned projects, internal and external audit observations related to operations quality, CAPA plans, procedural updates and other duties as assigned.  
• 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.  
• 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 12 years’ experience in a  quality engineering or quality systems role, or related experience in the medical device industry. Neurovascular/ vascular device experience preferred. 
• 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 all Post Market Surveillance processes.        
• 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 Audit Management skills and experience
• 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 compensation 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 compensation. The annual salary range for this full-time, exempt position is between $160-185K.

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.

Salary : $160,000 - $185,000