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Supplier Quality Engineer II in San Diego, CA at Apex Life Sciences

Date Posted: 11/21/2018

Job Snapshot

Job Description


Summary:

Under minimal supervision, the scope of this position is supporting supplier selection, evaluation, qualification and performance monitoring.

Tasks and Responsibilities:

  • Responsible for the supplier quality program.
  • Oversees qualification of suppliers, which includes but is not limited to evaluating suppliers through questionnaire review and performing desktop and onsite audits of suppliers.
  • Responsible for performance monitoring of suppliers including preparation and distribution of quarterly supplier dashboards and preparation of monthly metrics on supplier performance.
  • Responsible for coordinating non-conformances with the suppliers and documenting these activities.
  • Oversees the supplier notification program including initial assessment of impact when supplier notifies of changes and development of action plans through to final resolution.
  • Responsible for development of Quality agreements with suppliers to ensure roles and responsibilities are clearly defined.
  • Identify quality system improvements and be the subject matter expert responsible for the supplier quality program.
  • Provide support and data as needed for design reviews, quality management reviews, internal and external audits.
  • Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Carries out duties in compliance with established business policies.
  • Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA and other regulatory agencies.
  • Understands and is aware of the quality consequences, which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities
  • Knowledgeable of federal and other regulations, e.g. QSRs, ISO 13485, CMDR, etc.
  • Perform other duties & projects as assigned.

Education/Experience:

  • BS/BA degree in science or technical discipline.
  • 3-5 years related experience.
  • Supplier auditing experience
  • Knowledge of REACH, roHS, requirements, restricted substance requirements.
  • Component engineering experience
  • Experience with federal, 3rd party agencies or regulatory agencies, e.g. QSRs, ISO, ISO 13485, CMDR) and statistical sampling plans.
  • Ability to work on multidisciplinary teams.
  • Identify and address compliance issues with small to medium complexity.
  • Demonstrate problem-solving and troubleshooting skills
  • Strong verbal and written communication skills
  • Organized and detail oriented

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




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