The Supplier Quality Engineer is responsible for ensuring all materials used in the manufacture and customer delivery of Nonin products meet the design, quality and value mission in accordance with corporate objectives and customer requirements.
Essential Job Functions:
- Ensure Supplier Quality activities, policies, processes and procedures are focused on the highest standards of quality, continual improvement and customer satisfaction.
- Provide Supplier Quality Engineering technical support for receiving inspection department.
- Perform on-site supplier audits.
- Provide input as a materials review board (MRB) member and be the primary conduit to resolve all supplier non conformances.
- Ensure compliance with all applicable regulatory requirements.
- Provide supplier; quality, manufacturing and technical representation on Product Development Teams to ensure new product manufacturability and support successful market introductions. Participate in design review activities to assure prints and specifications clearly define Nonin requirements.
- Aggressively and proactively ensure the rapid response and successful resolution of supplier quality issues in order to minimize or eliminate potential business interruption.
- Collaborate in the development and implementation of manufacturing and inventory initiatives. Ex. LEAN mfg, demand-pull, continuous flow.
- Establish and implement effective supplier selection, qualification and approval mechanisms for use by Nonin Medical, Inc.
Required Education & Experience:
- Bachelor’s Degree in engineering; or equivalent combination of education and experience.
- 2-5 years Supplier Quality Engineering experience or equivalent.
Required Knowledge, Skills, and Abilities:
- Knowledge of FDA QSR requirements.
- Knowledge of ISO and other recognized international quality system standards.
- Knowledge of world class quality techniques and implementation.
- Demonstrated ability and knowledge of inspection techniques and requirements.
- Demonstrated ability to work in a highly regulated environment.
- - 5-10% domestic & international travel
- Good communicator with the ability to influence and persuade across all levels of the organization as well as with suppliers and customers, exercising a high degree of tact and diplomacy to accomplish objectives.
- Good interpersonal, project management and presentation skills, with the ability to clearly present recommendations and ideas and to summarize complex issues.
- Ability to work well under pressure in a fast-paced, time-sensitive environment with shifting priorities and multiple deadlines.
- Self-Starter; Highly Organized; Complex Problem-Solving; Strong Analytical Judgment; Technical Detail-Oriented; Administrative
- High Standard of Integrity & Ethics; Customer-Focused, Creative & Innovative; Positive Attitude; Aggressive in the pursuit of goals; Results-Driven; Action-Oriented, Flexible & Adaptable
- Experience with FMEA, DOE, SPC and related statistical tools.
- Experience with electronic components, PCB assemblies, injection molded parts, mechanical assemblies, medical products.
- Lean manufacturing and continual process improvement experience.
- Sit/stand/walk 8 hrs/day.
Nonin Medical is an Equal Opportunity/Affirmative Action Employer - Minority/Female/Disabled/Veteran.