Sr. Quality Systems Specialist

RESPONSIBILITIES

• The Senior Quality Systems Specialist provides support for risk assessment, CAPAs, supplier management, document control, internal audits, health hazard assessments and post market surveillance activities.
• Provides technical guidance and support for product development, sustaining engineering, production, and quality activities to assure conformance to established QMS processes.
• Provides guidance in interpreting external regulations, agency guidelines, and internal policies to assure compliance.
• Facilitates the optimization and continuous improvement of internal operations to meet department, quality, and company objectives.
• Identifies risk and evaluates deficiencies while working with internal departments/business units to appropriately provide corrective action.
• Facilitates internal training and process improvements on quality assurance requirements, processes, and procedures.

REQUIRED EDUCATION AND SKILLS

• Must have comprehensive knowledge of U.S. FDA medical device laws and regulations, Quality System Regulation (QSR) and MDSAP requirements.
• Must have comprehensive knowledge of ISO 13485 international standard for quality management systems.
• Comprehensive knowledge of the MDD/CMDR and other international medical device regulations is required.
• Experience defining quality management system architecture and developing SOP’s, templates, and forms required.
• Comprehensive experience in risk management, CAPA management, Internal auditing, supplier controls, statistical techniques and process improvement tools.
• Comprehensive knowledge of IEC 62304 Medical Device Software Lifecycle standard, EN 62366 Engineering Usability standard and risk management principles (ISO 14971).

Preferred:

• Five to ten years experience in medical devices and in multiple quality system elements and processes preferred.
• Working knowledge of MDR desired.
• Bachelors Degree in Biology, Statistics, Science or Business preferred.
• Experience with software medical device product development, artificial intelligence and machine learning is highly preferred.
• Certification in Quality, Auditing, Six Sigma, or Configuration Management highly desired.
• Experience with implementation of computer-based quality management systems and applicable regulations (21 CFR Part 11) highly desired.

SKILLS AND OTHER REQUIREMENTS

• Ability to establish and maintain a close, effective working relationships with R & D, Marketing and other technical personnel at all levels.
• Strong working knowledge of software development, verification and validation processes.
• Ability to work on multiple concurrent tasks/activities and meet corporate strategies.
• Demonstrated proficiency with developing, implementing, and managing Quality programs Ability to work closely with others in high demand situations. 
• Strong technical, analytical and problem-solving skills, including strong project management skills
• Requires demonstrated, excellent written and verbal communication skills.

COMPANY VALUES

Integrity, Customer Focused, Collaborative, Problem Solvers and Drive

WHAT WE OFFER YOU

Vital offers a dynamic work place, competitive compensation package, and room for learning and growth in our organization. This is an environment in which things move quickly and you’ll have the opportunity to wear many hats. We have a casual dress code, offer flexible work hours and actively foster work-life balance, because anything else simply isn’t sustainable. Our Minnetonka, MN office is located about 12 miles southwest of downtown Minneapolis. Our office is near several walking paths and restaurants that are a quick drive away. In our office of 170, we have free healthy snacks, a deli on site and Friday massages. Our team at Vital loves what we do and has fun doing it together. We look forward to receiving an application from you.