Job Title: Quality Engineer
Location: Mansfield, MA
Duration: 6+ months (possibility of extension)
JOB ROLES & RESPONSIBILITIES:
Principal Risk Management Specialist
· This position will lead risk management related activities for existing devices and support post-market quality by assisting with analysis and investigation of product or quality system issues and carrying out continuous improvement efforts.
· Primary responsibilities for this position include risk assessment, maintenance, and management as documented within the risk management files, providing post market quality support and guidance through nonconformity assessment, supporting health hazard assessments, and contributing to the various aspects of CAPA such as containment determination, root cause investigation, and corrective action planning by utilizing their subject matter expertise across the organization.
ESSENTIAL FUNCTIONS:
· Support, Collaborate and drive post market quality activities with cross functional partners (R&D, manufacturing, post market vigilance, CAPA, change development, Supplier Quality, etc.) to ensure the proper application, use and updates of risk management files following product launch.
· Collaborate with Clinical personnel on creation of appropriate harm/hazard analysis (HHA and RMF) for issues potentially impacting users and patient outcomes. ? Provide assessment of post-market risk related to field issues and provide response to regulatory body inquiries as necessary.
· Support Post Market activities related to product design and production in accordance with applicable procedures.
· Initiate, drive, or support CAPA related to product performance, compliance, or continuous improvement.
· Maintain knowledge base on new regulations and standards that affect Risk Management for medical devices.
· Drive continuous improvement efforts, through facilitating, leading, and collaborating with cross functional teams including Quality, R&D, Marketing, and Medical/Clinical Affairs.
· Ensure Risk Management Files are maintained per defined schedules and frequencies.
MINIMUM REQUIREMENTS:
· Education required/ preferred: B.S. in Engineering or associated scientific discipline.
EXPERIENCE
· Minimum 4 years medical devices experience in Quality or Development Engineer position.
SKILLS/COMPETENCIES:
· Working knowledge of product risk management standards and tools (ISO14971, IEC 60601, pFMEA, dFMEA, etc.).
· Working knowledge of Quality Engineering and medical device regulations (FDA 21CFR820, ISO13485)
Other Skills:
· Working knowledge of electro-mechanical devices, software hazards analysis, and/or plastics related manufacturing processes (i.e. extrusion, injection molding, RF welding, etc.) is preferred.
· Mastery of software programs - Microsoft Word, PowerPoint, Excel, and Project.
· Demonstrated ability to effectively influence and negotiate with all levels of an organization and leading effective/successful change initiatives.
· Broad business knowledge and ability to link customer needs with business.
· Self- starter, with the ability to work independently and with all levels of managers, associates, and clients.
· Proven ability to directly lead and/or co-lead multiple tasks and projects.
· Strong collaboration, negotiating, and conflict resolution skills.