Product Stewardship Engineer
1360-1380 South Loop Road Alameda, CA 94502 US
Job Description
Duties:
- Support the implementation of a product stewardship database,
- Ensure part, packaging and product information is accurately tracked in database,
- Work to Corporate Regulatory/Product Stewardship team and provide updates as needed,
- Ensure compliance with geography specific restricted substance requirements (e.g., RoHS, REACH, EU MDR) and Restricted Substance Management (RSM) requirements,
- Facilitate, track and work with various groups on component changes in the manufacture, import and distribution of any new product or relocation of manufacturing processes,
- Facilitate division compliance with all RSM reporting requirements,
- Coordinate with R & D support, the implementation and integration of RSM evaluations,
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Supports Environmental Management System, ISO 14001 and division sustainability efforts.
- Performs other related duties and responsibilities, on occasion, as assigned.
Other:
- Medical device manufacturing experience preferred,
- Experience in restricted substance management (e.g., REACH, RoHS) preferred,
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Must possess critical thinking, problem solving and planning skills.
- Must use sound judgement and ability to build and maintain relationships with individuals and in teams.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
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