Vacancy expired!
Duration: 6-months Duties: Provide clinical expert knowledge and clinical guidance to Quality Engineering and other cross functional teams.Key Responsibilities: Provide medical/clinical guidance to complaint staff and engineers related to event interpretation, event investigation, proper coding, and required regulatory reporting (MDR, MDV, etc.). Obtain and evaluate information from clinical specialists, sales staff, physicians, nurses and other hospital staff/customers, as needed to support complaint investigation and drive towards resolution. May provide training to complaint staff on patient anatomy and medical conditions, products and procedure, and internal policies and procedures. Perform complaint trending analyses, participate in quality metrics review meetings. May analyze and interpret aggregate complaint data for a specific product line, business unit, regulatory submissions, regulatory agency requests, and/or management report including ad hoc report summaries. Communicate complaint data and relevant clinical information to internal customers in quality, manufacturing and new product development in support of complaint investigations Support process improvement projects as needed. Other incidental dutiesSkills: Additional Skills: Proven successful project management skills Strong presentation and public speaking skills Proven expertise in both Microsoft Office Suite, including advanced Excel and QMS (Quality Management System) Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives Extensive knowledge of own area within the organization while contributing to the development of new concepts, techniques, and standards Extensive understanding of FDA's Quality System Regulation Working knowledge of Medical Device regulations, such as FDA 21 CFR 820, ISO 13485; MDD; CMDR; MDD 93/42/EEC and other applicable regulatory requirements. Strict attention to detail Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization Ability to manage competing priorities in a fast paced environment Represents leadership on sections of projects within a specific area interfacing with project managers and quality compliance team Consult in project setting within specific sections of quality compliance area Provides quality compliance leadership to outsourcing partners on a task level Adhere to all EHS rules and requirements and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/controlEducation:Bachelor's Degree or Equivalent in in related field , 8 years years experience of previous related experience in a Medical Device Industry, Quality System, hospital/clinical environment (e.g. cardiac care, ICU, OR, or cardiovascular/endovascular interventions) ReqWe are an equal opportunity employer and make hiring decisions based on merit. Recruitment, hiring, training, and job assignments are made without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, or any other protected classification. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance.
- ID: #43710330
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State: California
Irvine
92614
Irvine
USA
- City: Irvine
- Salary: US61.88 - US63.88 per annum
- Job type: Contract
- Showed: 2022-06-30
- Deadline: 2022-08-28
- Category: Et cetera