Supplier Quality Engineer

REPORTS TO:             Quality Manager

DESCRIPTION

The primary purpose of this position is to develop the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP/ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance.

RESPONSIBILITIES

  • Adheres to Viant Values and all safety and quality requirements.
  • Quality representative for Supplier Quality activities, both troubleshooting Supplier-CAPA and continuous improvement initiatives (inclusive of Inspection and sampling reduction projects).
  • Develop, maintain and improve the supplier management program while assuring alignment and supporting Viant Medical Supply Chain Organization initiatives and policies
  • Determine strategies for continuous improvement in supplier quality and supply chain metrics and report plans/updates during Management Reviews
  • Manages supplier corrective action system (investigation, documentation and implementation of corrective action and the verification of their effectiveness)
  • Design and/or specify inspection methods, tools and test equipment to ensure product quality and design integrity are appropriately maintained. Also implements appropriate inspection sampling plans using statistical methods.
  • Manages the supplier requests for product and process changes
  • Review and approve changes to supplier related documents (procedures, drawings, etc)
  • Perform component qualifications, risk assessments and first article inspections (as required) prior to the supplier implementing and /or performing the change.
  • Participate in suppliers design review, product validation design verification, Risk Management plans/reports (dFMEA, pFMEA)
  • Perform risk analysis for existing and new raw materials/components
  • Develop and conduct statistically designed experiments to determine sources of materials/ component variability so the product quality is maintained or improved
  • Assist with Supplier Transfer projects from planning stage through qualification.
  • Monitor and assure Viant supply chain activity and procedure set is compliant to applicable sections of FDA quality system regulation and ISO 13485 regulation.
  • Performs other functions as required.

REQUIREMENTS

EDUCATION

  • Bachelor’s degree in Engineering.
  • Six Sigma Black Belt Certified, Certified Quality Engineer or Auditor preferred

EXPERIENCE

  • 5 – 8 years of experience in Quality, Supplier Quality, Supply Chain or related process driven field.

SKILLS/COMPETENCIES

  • Negotiating, influence and leadership abilities.
  • Computer knowledge: MS Excel, MS Word, MS Power Point, Minitab.
  • Knowledge of ISO 13485 and FDA QSR
  • Quality System Audits knowledge.
  • Good manufacturing and documentation practices.
  • Drawings and blueprints knowledge.
  • Measurement and test equipment knowledge.
  • Excellent communication (written and verbal) skills with internal and external customers.
  • Presentation skills.
  • Ability to work in a matrix organization, strong analytical skills.
  • Problem solving and skills.
  • Proven leadership, communication, and project management.
  • Understanding of ROHS (Restriction of Hazards Substances in electrical equipment), REACH (Registration, Evaluation, Authorization and Restriction of Chemicals in making the product), Animal derived agents, Prop 65 and conflict minerals preferred

PHYSICAL REQUIREMENTS

  • Light work: Exerting up to 50 pounds of force occasionally, and/or up to 10 pounds of force frequently, and/or lift, carry, push, pull, or move objects. Travel required (up to 5%)

WORK CONDITIONS

  • Worker is not subject to noise, vibration, hazards, etc.

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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.