Supplier Quality Manager

Merit Medical Systems, Inc.•South Jordan, UT

19h•Onsite

About The Position

This position is responsible to establish and maintain procedures ensuring that all purchased and received product and services (outsourced, subcontractors and consultants) conform to specified requirements. This position is responsible to ensure that process validations, test method validation, specifications are conforming to requirements.

Requirements

Education and/or experience equivalent to a Bachelor's Degree in Engineering or related field.
A minimum of six years of supplier quality and risk management (ISO 14971) experience.
Excellent interpersonal, and oral and written communication skills.
Problem solving and conflict management skills.
Excellent organizational skills and the ability to work under strict time constraints.
Strong analytical skills and attention to detail.
Demonstrated computer skills preferably spreadsheets, word processing, database and other applicable software programs.

Nice To Haves

Supplier quality metrics/agreements/risk mitigation program/reports
Supplier approval process
Continuous improvement
Computer skills

Responsibilities

Establishes and maintains the requirements, including quality requirements, which must be met by suppliers, contractors or consultants.
Ensures that Merit documentation sufficiently describes the product and/or services to be supplied and meets the requirements for approval of product; inspection / acceptance procedures, processes and equipment; qualification of personnel and quality management system requirements are understood by suppliers and Merit personnel, as appropriate.
Establishes the evaluation, selection and re-evaluation processes needed to document the ability of the suppliers, contractors or consultants to meet specified requirements.
Defines the type and extent of control to be exercised over the product, services, suppliers and consultants based on risk to the finished product and on the supplier evaluation results.
Reviews and analyzes data related to supplier qualification and performance to specified requirements. Provide reports to management, as appropriate.
Maintains records of inspections or other activities demonstrating that the specified requirements have been met.
Ensures purchasing documents include, where appropriate, an agreement that the supplier shall notify Merit of any changes in the product or services. Ensures that changes do not affect the quality of the finished device or its legally marketed regulatory status.
Ensures records of corrective and/or preventive actions arising from the evaluation process and/or supplier approval documentation are maintained and reviewed by management. Identify areas of improvement and facilitate process improvement, as appropriate.
Ensure remediation activities are completed to schedule which include but are not limited to process validation, test method validation, and specification updates throughout the supply base.
Coordinates supplier related problems with Purchasing, Engineering and IQA, as appropriate.
Ensures that supplier related issues are addressed by Merit’s risk management process.
Provides input to and manages the department budget.
Provides adequate qualified resources to meet departmental objectives and support operations and quality needs.
Performs other related duties and tasks as required.