PLEASE REVIEW MINIMUM REQUIREMENTS AND JOB DESCRIPTION. IF YOU MEET MINIMUM REQUIREMENTS PLEASE SUBMIT YOUR RESUME FOR REVIEW AND WE WILL REACH OUT!
MINIMUM REQUIREMENTS:
To be considered for this role, please ensure the minimum requirements are evident on your resume.
Bachelors Degree in Engineering or Science field with 7+ years relevant experience, or Masters Degree in Engineering or Science field with 5+ years relevant experience.
5+ years experience demonstrating expertise in creating and maintaining ISO 14971 compliant risk management files.
Experience in 21CFR820, ISO13485, ISO 14971, CMDR and Medical Device Directive
Training in Risk Management, ISO 14971:2012
PREFERRED QUALIFICATIONS:
Previous experience working in a cross-functional team environment.
Familiar with reliability principles and tools
ASQ CQE, CQA, CSQE and/or CRE certification.
Familiar with statistical software tools (Minitab, Stat Graphics, Statistica),
Familiar with IEC 60601 and product specific industry standards.
DFSS / Lean Green Belt or Black Belt
CAREERS THAT CHANGE LIVES
The Minimally Invasive Therapies Group strives to enable earlier diagnosis, better treatment, faster complication-free recovery, and enhanced patient outcomes through less invasive surgical solutions. This position will work in collaboration with others to ensure design quality assurance, R&D regulations and consistent best practices in Risk Management.
Surgical Innovations sets the standard for Minimally Invasive Surgery (MIS) by creating innovative surgical products and services that focus on obesity and diseases and conditions of the gastrointestinal tract, lung, abdominal wall, pelvic region, and the head and neck.
JOB DESCRIPTION: A DAY IN THE LIFE
The Principal Quality Engineer- Risk Specialist will develop and manage the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.
Develop, manage, improve and maintains Ventilation Risk Management process. Ensuring the risk process and procedure meets ISO 14971 requirements.
Work closely with Medtronic global Risk management to ensure there are no gaps in Vent process and procedure.
Mentor and coach, Design quality assurance, R&D in Regulatory and Industry best practices in Risk Management.
Manage IIA: Issue Impact Assessment process and work closely with medical and DQE teams to improve the process. Review and mentor all the IIAs and Hazard Analysis.
Update all the marketed products Risk Management files.
Work closely with DQE and PMV to provide mentoring on risk assessment on complaints.
Work with global reliability SMEs to establish the reliability guidelines and process to entire product lifecycle.
Support RFAI and interactions with worldwide competent authorities & notified bodies.
Drive QMS & product continuous improvement through CAPA the process, CAPA investigations, CAPA & compliance audit trending of quality data streams.
Provide expertise and guidance in interpreting governmental risk regulations, agency guidelines and internal policies to assurance compliance.
Participate in PRA. DFEMA and PFMEA activities and provide guidance to team.
Evaluate corrective and preventing action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.
Lead process improvement projects and conduct training with Quality to improve Risk processes the GBUs overall quality system compliance.
Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Medtronic’s operations.
Prepare management reports depicting trends and useful data for management review purposes.
Support management during external inspections and participating in the management of external inspections as required.