Job Description
Working in the Design Quality team the qualified candidate for this hands-on position should excel in an environment that embraces teamwork, change, risk-based decision making and flexibility. This individual should be willing to make a significant contribution to a multidiscipline team, must be self-motivated to take action, and have excellent written and verbal communication skills. Candidate will support efforts to ensure EU MDR COMPLIANCE. Must have a strong compliance background and experience with MEDICAL DEVICE REGULATIONS.
POSITION DUTIES & RESPONSIBILITIES:
· Provide support for review of existing documents, assessing gaps, revising documents, creating design engineering rationales to meet EU MDR requirements.
· Review and approve DESIGN DOCUMENTATION INCLUDING VERIFICATION & VALIDATION RATIONALES,RISK DOCUMENTS (DESIGN AND PROCESS), STANDARDS EVALUATIONS, MECHANICAL TEST PROTOCOLS ANDREPORTS.
· Support risk management activities including planning, design & CLINICAL RISK MANAGEMENT DFMEA, PRODUCTION RISK MANAGEMENT PFMEA, AND OVErall risk summary reporting.
· Revise, review and approve verification and validation activities as required.
· Review and approve any required drawing updates, including design impact assessments.
· Review and approve any labeling updates, including design impact assessments.
· Deliverables to be quarterly based on assigned files.
· Apply statistical methods and design/process excellence tools to support design engineering rationales/memos as required.
· Provide leadership in all areas of the Quality System, including, but not limited to corrective & preventive actions, product complaints, post market surveillance, NONCONFORMING MATERIALS, RISK MANAGEMENT, AND AUDIT SUPPORT FUNCTIONS.
· Provide leadership in the understanding of medical device regulations to other disciplines.
· Ability to work in a team setting within Design Quality and cross-functionally is required. Communicate effectively at all levels within Quality, as well as cross functionally with departments such as Product Development, Regulatory, Medical Affairs, Manufacturing, and Marketing. Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times.
Report task progress and status on a weekly basis
Qualifications
· A minimum of BACHELOR'S DEGREE IN ENGINEERING or related technical or scientific discipline with a minimum of 5 years of experience in related field are required.
· STRONG DESIGN/QUALITY ENGINEERING SKILLS with a proven track record in all aspects of the design control process, including functional/design requirements, design verification/validation, and product risk management are required.
· Proven track record implementing Quality System improvements to meet compliance and overall business goals.
· CHANGE CONTROL EXPERIENCE (REVIEWING AND APPROVING DESIGN ENGINEERING CHANGE ORDERS THROUGH A PLM SYSTEM) is required
· Proficiency utilizing MS Office Suite (Word, Excel, PowerPoint etc.) is required.
· Candidate should possess excellent problem solving, decision-making, and rootcause analysis skills in addition to interpersonal skills that foster conflict resolution as it relates to technical situations.
· Strong written and verbal communication skills are required, as is the ability to effectively communicate with cross-functional teams and program managers.
· WORKING KNOWLEDGE OF DESIGN CONTROLS, GMPS, QSR (21 CFR 820), MDD 93/42/EEC, ISO13485 AND ISO14971 QUALITY REQUIREMENTS is preferred.
· Previous experience in a medical device or a healthcare discipline is preferred. Previous Quality Engineering experience is preferred.
· Working knowledge OF MATERIAL SCIENCE AND MECHANICAL PRODUCT KNOWLEDGE is preferred.
· Development and/or manufacturing experience is preferred.
· Blueprint literacy including GD&T IS preferred.
· Knowledge of process and design excellence tools is preferred.
Additional Information