Supplier Quality Engineer

MAIN PURPOSE OF JOB

The Supplier Quality Engineer (SQE) acts as the primary contact with suppliers on all quality related issues. This individual will be responsible for all supplier management activities, interactions, and continuous improvement initiatives. They provide supplier related support to production and receiving inspection teams and will lead to resolve any non-conformity that is resulted due to supplier performance. The SQE is in charge of monitoring parts from acquisition through the inspection and manufacturing cycle, and is responsible to communicate and resolve supplier-related process problems.

MAIN JOB RESPONSIBILITIES

  • Follow and ensure personnel comply with FDA Quality Systems Regulation, ISO Standards and SOPs as defined by Viant Medical’s policies and procedures.
  • Authorizes Quality Department approval signature for Change Orders
  • Ensures that all record keeping and documentation is completed in a timely manner according to established policies and procedures
  • Develops and recommends plans, programs and policies required to meet established objectives and industry standards
  • Assists suppliers in Qualification/Validation activities for production/manufacturing processes
  • Continuously reviews methods, procedures, processes, etc. to determine improvements related to quality and cost to increase efficiencies
  • Motivates peers to recommend improvements
  • Independently performs process capability and performance studies with suppliers; recommends and, upon approval, assists suppliers with implementation of changes and upgrades to systems, procedures and processes to improve product quality
  • Independently leads problem-solving efforts with suppliers, including customer complaint investigation and analysis to identify and resolve sporadic and chronic quality issues to ensure production of safe and effective medical devices
  • Ensures that documentation and findings are completed in a timely manner and in compliance with FDA standards and procedures and recommends actions or changes to improve quality
  • Assesses compliance with applicable regulations within the manufacturing processes and recommend improvements to ensure suppliers provide safe and effective products
  • Provides written reports and supporting documentation of compliance and for recommendations
  • Requests training or training support as needed
  • Leads Supplier Quality System audits
  • Participates in internal audits.
  • Responsible for maintaining Approved Supplier List
  • Responsible for reporting, follow-up, and closure of supplier SCARs
  • Assembles presentations on supplier issues and metrics for management reviews
  • Maintains effective working relations, communications, and feedback with all internal and external customers.
  • Performs other duties as required

POSITION REQUIREMENTS

KNOWLEDGE/EDUCATION

  • BS in Engineering or related field or equivalent in experience and training
  • Experience in Customer Focused Quality and/or Business Process Improvement
  • Knowledge of FDA QSR, ISO13485 and ISO14971 Risk Assessment

JOB EXPERIENCE

  • 3-5 years’ experience
  • Experience in medical devices or Regulatory/FDA or ISO manufacturing setting preferred
  • Internal/External Auditing experience preferred

SKILLS/COMPETENCIES

  • Project Management
  • Lean Manufacturing experience
  • Customer Focused Quality
  • Quality Engineering Statistical Tools
  • Reliability Engineering Statistical Tools
  • Influence Management
  • Working knowledge of statistical techniques
  • Working knowledge of quality and reliability software
  • Ability to work in a team environment
  • Working knowledge in spreadsheets, databases and word processing software programs
  • Knowledge of FDA QSR, ISO13485 and ISO14971 Risk Assessment

PHYSICAL REQUIREMENTS

  • Bend/Stoop/Kneel .25 hr./day

  • Lift/Carry 10-25 lb. 2x/mo

  • Stand/Sit/Walk 6 hr./day

  • Excellent vision

  • Up to 25% travel required

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ABOUT VIANT

At Viant, we focus on providing end-to-end solutions for medical device OEMs. Our deep materials expertise—combined with our experience in engineering, manufacturing, assembly, packaging, and sterilization—allows us to bring our customers’ healthcare solutions to market. We have facilities across the U.S. and around the world, including low-cost facilities in Costa Rica, China, Mexico, and Puerto Rico. Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.