Supplier Quality Engineer

Pay Range: $88.33hr - $93.33hr

Job Overview:

The mission of Supplier Engineering is to ensure high quality and stable delivery of purchased production components from suppliers operating under robust quality systems. The candidate is responsible for ensuring suppliers meet the organization's requirements for product quality, cost, and service. Joining the team means joining a group dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as the highest priority.

Responsibilities:

Project Management / Project Coordination / Manage Change

• Drive actions for magnet qualification and risk mitigation project work streams.
• Prepare reports to support executive management escalations.
• Manage the planning and implementation of supplier change management projects using the Supplier Change Request process (SCR) post Design V&V.

Part Qualification:

Support Value Engineering and Quality Improvement Part Qualification efforts

• Drive agreement in defining appropriate Part Qualification requirements.
• This includes defining testing and inspection requirements prior to system integration to maximize factory efficiency.

Support transfer of parts between suppliers:

• Complete Production Part Qualification Process deliverables: Supplier pFMEA, Special Process Validations, FAI, and Process Capability Analysis.
• Perform product/process risk analysis and ensure mitigations are implemented and effective prior to product introduction.
• Establish sustainable process capability at supplier and critical sub-tier suppliers.

Requirements:

In order to adequately perform the responsibilities of this position the candidate must possess:

• BS degree in Engineering field.
• 2+ years related experience in Manufacturing, Supplier Process Engineering, Design, or related field.
• Excellent organizational skills.
• Ability to track and report on multiple work streams.
• Strong verbal and written communication skills.
• Ability to read and interpret detailed specifications and schematics and communicate technical information.
• Significant computer experience using Windows, Word, Excel, Access and ERP Information Systems, preferably SAP.

Preferred Qualifications:

• Experience with low-volume high-mix production environments is preferred.
• Working knowledge of magnet-related components, including design considerations, manufacturing processes, and testing/qualification methods.
• Experience with multiple manufacturing processes including understanding of key input variables for quality, cost and capacity.
• Desired product experience in Plastic Injection Molding, Mechanical Motion Products (Bearings, Gears, Screws), or Mechanical Motion Control Products (Motors, Brakes).
• Ability to motivate suppliers and lead teams to solve difficult technical and process problems.
• Knowledge of pFMEA, process validation, inspection and test techniques.
• Understanding of GDP and QMS methods, ideally familiar with 21 CFR part 820 and ISO 13485.