Quality Manager

Position Overview
Sunrise is looking for a senior quality manager with deep skills and experience managing an ISO 13485 certified medical quality management system (QMS) in an environment that includes the development of compliant and highly reliable medical systems including software, mechanical, and electronics.  Software Quality Assurance (SWQA) and automated test experience is a plus.

The Manager or Director will be responsible for the design and achievement of company goals with respect to the provision of quality design services delivered to a wide variety of clients. This manager will also be responsible for the selection, motivation, and oversight of staff for the achievement of Sunrise’s quality objectives.

With the appropriate engineering experience, the manager will understand how to construct and maintain a quality management system that complies with FDA and international standards and our clients’ quality system needs; at the same time remaining flexible and lean to efficiently satisfy a broad range of clients’ business needs.  This individual will have a collaborative approach to the achievement of goals, be team-oriented, and have a hands-on approach.

Duties and Responsibilities
  • Take primary responsibility for the implementation and management of FDA 21 CFR 820 and ISO 13485 compliant quality system.
  • Manage external quality relationships with clients and Notified Bodies, including audits.
  • Conduct internal and external audits.
  • Work with top management to develop, plan, and implement company quality objectives and initiatives.
  • Ensure that the organization’s services meet customer requirements and applicable quality standards.
  • Take responsibility and authorization to ensure the promotion and awareness of regulatory and customer requirements throughout the organization.
  • Keep company apprised of expected changes to the quality landscape affecting business performance.
  • Direct quality engineering in identifying, recommending, implementing, managing, and administering process and software validations.
  • Take responsibility for implementation and maintenance of the company quality system.
  • Oversee the company's compliance to the prescribed quality certifications by assessing, reporting, and implementing new and changing regulations.
  • Create and support effective process enhancement initiatives to maintain an environment of continuous improvement throughout the organization. Provide effective leadership support, training, and guidance to all company employees.
  • Support proposal creation and estimates.
  • Direct verification of electrical, mechanical, and software as applicable
Qualifications
  • Bachelor’s degree in Engineering, Science, or similar technical discipline
  • 6+ years experience in Quality Management including medical device design controls
  • Extensive knowledge of ISO 13485, and global quality assurance requirements for medical devices, including IEC 60601-1
  • Excellent analytical and decision making skills, as well as strong communications and people management capabilities
  • Proven managerial and leadership skills, with the ability to lead, motivate, and develop staff
  • Ability to speak effectively before groups of clients or employees
  • Solid understanding of IEC 62304 Medical Software Development Process
  • Risk Management standards including ISO 14971:2012
  • Usability Standard, IEC 62366-1
  • Quality Assurance/Quality Management Systems
  • Statistical Methods
  • FDA Process Validation Guidelines
  • Experience using a variety of software development methodologies (Waterfall, Phase Gate, Agile, SCRUM, Kanban, etc.)
  • Experience in modern test automation is a plus
If you are up for the challenge and excited to work with an exceptional team of professionals, we invite you to send your resume and cover letter to Human Resources: personnel@sunriselabs.com