Careers

Careers

Careers

Director, Quality Assurance and Regulatory Compliance

Job description

The Director, Quality Assurance, oversees all quality functions for the Company, including but not limited to, Quality Engineering, Quality Assurance, Quality Control, Document Control, and Quality Systems. This is a hands-on position requiring direct involvement with day-to-day quality engineering, quality assurance, and quality systems oversight. This individual will be responsible for implementing product and process quality improvement projects for Class III devices distributed in a worldwide market. Maintaining ISO 13485 compliance and other worldwide regulatory standard requirements is a critical element of this role.

The Director, Quality Assurance will be the QMS management representative for the Company.

Essential Duties and Responsibilities include the following:

  • Direct activities for the quality assurance group at CardioFocus. Manage quality function to support product development operations, and sales with a focus on design controls for development.

  • Active participant and responsibility for the hosting of external and internal audits including coordination with auditing groups(s) and internal stakeholders throughout the audit process.

  • Demonstrated experience supporting R&D engineering, manufacturing, and sustaining projects through all phases of the product life cycle.

  • Overseeing the preparation of and reviewing/approving validation protocols and reports, risk analyses, and standard operating procedures. May be involved in regulatory submissions.

  • Responsible for supporting operational/QA activities, such as complaint handling, non-conforming material disposition, corrective and preventive actions, internal and external audits, calibration, document control and training tracking requirements for the Company.

Qualifications

Core Competencies/Skill and Abilities Required:

  • Ability to lead by example to oversee and mentor direct reports in the quality department.

  • Strong and thorough knowledge of quality engineering tools and concepts.

  • Quality Management Systems development, maintenance, and auditing per ISO13485/EU MDR/FDA QSR.

  • Quality planning, data collection, and charting and statistical methods, including sampling.

  • Must have excellent organizational and problem solving skills. Must have excellent people skills and be able to interface well with all level of employees at the Company. Must be thorough and detail-oriented. Must have excellent reading, writing and communication skills in the English language. Must be able to work independently and collaboratively across the Company with little supervision and lead a team to achieve company goals.

The above information (essential duties and responsibilities) on this job description are designed to present the most essential job duties and responsibilities necessary to achieve the job's end results. It is not intended to be a comprehensive list of all duties, responsibilities, and qualifications.

Qualifications:

  • Bachelor’s degree (B.S.) or equivalent in related field.

  • Minimum of 7 years related experience in an FDA QSR, ISO 13485, and EU MDR compliant environment.

  • Strong and thorough knowledge of quality engineering disciplines and Quality Systems development, maintenance, and auditing per ISO13485/FDA QSR/EU MDR. Experience overseeing medical device quality department, supplier management including sterilization suppliers, and interacting with EU MDR Economic Operators from quality and regulatory compliance perspective.

  • FDA inspection/ISO audit hosting experience.

  • Cardiac catheter and FDA/EU Class III medical device experience a strong plus.

Physical Demands:

Normal day to day responsibilities in a production cleanroom and office environment with routine sitting and standing.

Please submit your resume and cover letter to: careers@cardiofocus.com

500 Nickerson Road
Marlborough, MA 01752

© CardioFocus. All rights reserved.

500 Nickerson Road
Marlborough, MA 01752

© CardioFocus. All rights reserved.

500 Nickerson Road
Marlborough, MA 01752

© CardioFocus. All rights reserved.