Job Title-Medical Device & RegulationsEIS
New Product Development (NPD) Methodology and Management
Location: Irvine, CA
Role Descriptions: Under limited supervision and in accordance with all applicable federal state and local lawsregulations and Corporate Johnson Johnson procedures and guidelines the duties and responsibilities for this position are
Development and review of PDP (Product development Process) deliverables
Review and approve RD
Engineering protocol reports
Development of Risk management records (i.e. DFMEA) in collaboration with SMEs
Support and provide guidance on Validations
Support Quality Documentation
Support Root Cause Investigation and closure of NC and CAPA
Review and approve the Change Orders (CR CN)Support in Design Enhancement
Interpret new upcoming quality regulatory requirements and provide guidance
Work with cross functional teams and internal teams to create deliverables
Performs other duties assigned as needed
Generic Managerial Skills If any
Strong communication skills. Candidates must be highly proficient in reading writing and speaking English language.
Ability to multitask including ability to understand customer requirements retrieve relevant information and provide responses satisfactorily and with immediacy is required. Employee must be able to effectively prioritize and manage multiple activities and responsibilities.
Ability to understand and follow complex written procedures is required.
Ability to function in a team environment and deliver on team objectives is required.
Ability to make decisions and solve problems while exhibiting situational judgement.
Essential Skills: Strategic Hiring
Desirable Skills:
Keyword:
Skills: EIS : Medical Device & RegulationsEIS : New Product Development (NPD) Methodology and Management
Experience Required: 6-8
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