Supplier Quality Engineer

Job Description

As a Supplier Quality Engineer 3, you'll be responsible for working with Suppliers and Contract Manufacturing Organizations (CMO) to improving process reliability, repeatability, controls and resolution of quality issues. Supplier Quality Engineers must be proficient at process controls, project management, process validation and verification, test method validations, process improvement, supplier auditing, supplier management, and CAPA investigations. Position will have a focus on process development and validation, component / device quality, Quality plans, tool design and equipment requirements related to injection molding, blow molding, and high speed automation.

About the Role

As a Supplier Quality Engineer 3, you will be responsible for working with Suppliers and Contract Manufacturing Organizations (CMO) to improve process reliability, repeatability, controls, and resolution of quality issues.

Responsibilities

• Supports relationship with key suppliers, including CMO(s) and acts as Point of Contact for resolution of quality and technical issues.
• Functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities. These activities include :
• Supplier performance monitoring
• Tool Design and Process Development that drives zero defect approach to quality
• New Product Introduction (NPI)
• Area of concentration includes high speed automation, injection molding, & blow molding
• Component, tooling, and process validations / verification
• Test Method Validations
• Project management of supplier quality initiatives.
• Supplier selection, evaluations, and audits
• Corrective and Preventative Action (CAPA)
• Perform independent evaluation, selection, and application in making adaptations and modifications to projects.
• Receives assigned total project leadership responsibilities on a portion of major significant projects and will be given total management responsibility for smaller projects.
• Manages and provides leadership for the functional group’s development, direction, and effectiveness, adhering to organizational policies and processes and supporting overall business and corporate objectives.
• Implements and understands FDA or regulatory requirements as necessary.
• Applies technology principles to multiple tasks.
• Working knowledge of cross-functional and related technical areas.
• Highlights risks and understands how to approach and complete tasks, avoiding serious delays and considerable expenditure of time and resources.
• Advises team members pro-actively on technical ideas and promotes skill development of teamwork.
• Interacts with peers across projects to secure resources and commitments.
• Handles frequent inter-organizational and outside customer contacts.
• Represents the organization in providing solutions to difficult technical issues associated with specific projects.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.
• Presents effectively complex technical information / analysis, and responds to questions from technical staff members and management.
• Works cooperatively and effectively within a team environment to achieve common goals and results, often influencing the outcome of the team(s).
• Work direction responsibility may include technicians and junior engineers.
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

Qualifications

Required Skills

Equal Opportunity Statement

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

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