Sr Supplier Qual Engineer in Santa Ana, CA at Apex Life Sciences

Date Posted: 6/1/2018

Job Snapshot

Job Description


Seeking a Sr. Supplier Quality Engineer for a medical device company located in Santa Ana, California. All qualified applicants should send a copy of their resume to jhambrose@apexlifesciences.com for immediate consideration.

Job Responsibilities:

  • Support overall sustaining supplier control processes including supplier performance management, change management, supplier audits and supplier CA/PA management
  • Drive supplier improvement/corrective actions through the following activities:
    • Work with the suppliers to drive corrective/preventative actions based on customer complaints, feedback from incoming inspection and manufacturing. Monitor for desired results
    • Lead and work with production to implement supplier related improvements for current products and manufacturing processes.
    • Lead Qualification and Validation activities including plans and reports for supplier related processes (e.g. process change, tooling changes, supplier moves, special processes).
    • Provide technical assistance to suppliers/others for qualification/validation testing. Assure resolution of issues during testing.
    • Partner with the procurement department in supplier optimization efforts. Tasks include selection and evaluation of suppliers based on supplier competencies, quality systems and performance/track record.
  • Oversee Supplier Change Control for assigned suppliers.  Review Supplier related changes to aid in the correction of process, design or material problems. This will  include (but is limited to preparing and releasing change orders for documentation changes, for the review/preparation of  test plans and reports (qualification, validation) for the assigned supplier changes, design revisions and other performance improvement activities (transitions, vendor certifications, vendor performed special processes). 
  • Lead or participate in the audit/assessment ensuring compliance with associated company policies, GMP/ISO requirements and regulatory bodies.
  • Support creation and maintenance of supplier related metrics to track supplier performance, identify and implement opportunities for supply chain improvements.
  • As appropriate, provide input into the design and manufacturability of new products and coordinate activities with suppliers.
  • Establish and create Supplier Quality Agreements with key suppliers based upon business and product risk.
  • Develops and implements systems and processes for supplier management that are in compliance with corporate policies, FDA’s QSRs, ISO 9001, IVDD, CMDCAS, CMDR, ISO 13485, MDD/EN46001 and other quality requirements, regulations and guidelines.
  • Responsible with supplier for the complete resolution of supplier related defects. This will be handled the following processes: NCMR, SCAPA and CAPA.  With ownership to assure all corrective actions are in place and effectively implemented.
  • Drive sub-tier supplier requirements and monitoring as defined in the risk management assessments.
  • Other responsibilities as assigned by the supervisor

Required Knowledge and Experience:

  • BS/BA Degree in Engineering or Science
  • 5 years of related experience
  • 3 years of experience in medical devices or related, regulated industries
  • Understanding of supplier quality management
  • Proficiency in Microsoft Office & Project

Desired/Preferred Knowledge:

  • Use and understanding of statistical tools
  • ASQ Certification
  • Six Sigma and Lean experience
  • Ability to work in a collaborative and cross functional team environment

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 employeeservices@apexsystemsinc.com or 844-463-6178.

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