Provide support for all Supplier Quality related activities.
- Enable reporting of metrics for monthly reviews
- Lead quality issues with suppliers & partner with Internal Customers; Lead effective supplier containment and corrections/corrective actions
- Act as point of contact for Internal/ External Customer groups on key compliance issues related to assigned suppliers
- Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB, Notified bodies, etc)
- Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes
- Ownership and reporting on all quality issues associated with the assigned suppliers. Ensure all assigned supplier related material quality issues are effectively communicated to key stakeholders
- Maintain structured communication channels with strategic sourcing, identifying responsibility by commodity / supplier.
- Liaising with the Manufacturing and Quality groups, in assessing and addressing material quality issues with assigned suppliers.
- Maintenance of the Approved Supplier List (ASL) in conjunction with the Global Sourcing, Supplier Controls and Audit functions .
- Participate as required in SCRB in conjunction with key stakeholders
- Support ECR process in local change control systems
- Participate in supplier reviews for assigned suppliers as required
- Participate in cross functional projects both locally & globally as required
- Partner with SQM functions and Strategic Sourcing on the developments and approval quality assurance agreements with suppliers.
- Technical understanding of manufacturing prints and tolerencing
- Strong communication skills
- Strong problem solving skills
- Strong team player
- Good understanding and ability to work with Microsoft Office
- Basic understanding of manufacturing processes
- Fluent in written & oral English
- Willing to travel in support of business needs to different geographical locations
- Basic understanding of project management
- Demonstrated interpersonal skills
- Ownership for supplier quality performance and measurement including KPIs and participate in supplier performance reviews.
- High level of detailed accuracy is required
- Previous EU MDR implementation experience is a plus
We put our Ambassadors first. When it comes down to it, we know we can't fulfill our Promise to our business customers without your commitment. You represent our organization while on assignment. In return, we do our best to show our commitment to you. Our Ambassador Benefits package includes: Medical, dental and vision coverage. It also includes 401k, sick time, holiday and much more. We are an equal opportunity employer.
We 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.