Supplier Quality Engineer

Description

Fully on-site, with limited domestic travel (reimbursed)

Key Responsibilities 

• Provide supplier quality services for raw materials, components, subassemblies, and service suppliers
• Conduct technical reviews with suppliers to ensure capability to meet specifications
• Oversee first article inspections, corrective actions, and continuous improvement
• Issue and manage CAPAs: SCARs (internal nonconformities) and SACAs (from supplier audits)
• Collaborate on root cause analysis and problem-solving
• Support post-market surveillance and material disposition
• Maintain records in Agile QMS (training provided)
• Participate in supplier audits as a subject matter expert
• Attend level 2 operational meetings and coordinate specification changes
• Generate or support supplier scorecards and performance metrics
• Assist in supplier qualification (IQ/OQ/PQ)

Required Skills & Experience 

• Experience: 2–3 years preferred; 5+ years considered overqualified
• Background: Regulated industry (preferably medical devices)
• Must-Haves: ISO 13485, CFR Part 820, CAPA and root cause analysis, IQ/OQ/PQ
• Nice-to-Haves: PPAP experience, Gage R&R, MSA, European MDR, risk management standards

Team Dynamics

• Works closely with manager and two engineers in Cimarano
• Collaborates with senior engineer Jonathan Farnsworth in Londonderry
• Expected to be the face of Client to suppliers – strong communication and soft skills required

Physical Demands: 

The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 

• Sit; use hands to finger, handle or feel objects, tools, or controls.
• Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl.
• Exposure to moving mechanical parts, vibration and/or moderate noise levels.
• Safety Shoes with Impact and Compression Protection Must be worn in designated areas.
• Travel (please specify): Domestic and International. 

Qualifications/ Skills:

• Communication—must be able to effectively communicate in both written and verbal forms, and at all levels in the organization.
• Ability to use problem-solving tools (SPC, TQM, etc.) to optimize processes.
• High proficiency with Microsoft Office suite to produce reports, analyze data, etc. effectively.
• Ability to handle and manage multiple complex projects.
• Knowledge of project management techniques.
• Working knowledge of  CFR 820, ISO-13485
• Validations (IQ, OQ, PQ) and root cause analysis (CAPA process).
• Statistical Process Controls (SPC) and statistical sampling know how.
• Must be able to follow applicable regulations (e.g. FDA, Canada, Brazil, Japan, etc.)

Education 

• Bachelor’s degree from a university in an Engineering field. 

Computer tools and knowledge required (Desirable):

• Microsoft Office
• Internet
• Email