Supplier Quality Engineer II (QMS) in San Diego, CA at APEX Systems

Date Posted: 6/20/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    San Diego, CA
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    6/20/2019

Job Description

Job #:  982076


Supplier Quality Engineer
San Diego, CA

Summary 
This role provides technical and quality support for supplier selection, qualification, and approval. There will be responsibility for ensuring that the supplier audit program is implemented in compliance with existing procedure requirements including audit schedule and execution, supplier auditor qualifications, adequacy of audit reports, and on time closure of audit non-conformances. 

Tasks and responsibilities: 

• Apply QSR 21CFR Part 820 (Medical Devices) to everyday application of Supplier Quality Management activities. 

• Support the qualification of new suppliers/services provides according to company policy. 

• Execute duties per the Supplier Quality Audit program. 

• Execute and support activities to ensure effective monitoring of supply chain performance including supplier corrective actions (SCAR) 

• Support the creation and management of quality agreements with vendor. 

• Manage supplier change control and work with the Operation/Quality engineering group to evaluate the change impact to product performance. 

• Lead and drive proactive supplier quality tools (e.g. scorecards, supplier risk management) and participate in supplier business reviews. 

• Leading and/or supporting supplier related Non-conformance and CAPA. 

• 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. 

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices. 

• 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. 

• Perform other duties & projects as assigned. 

Education/Experience: 

• Bachelor’s Degree in a biological science or engineering discipline. 
3-5 years of relevant medical device experience 

• Working knowledge of the technical principles related to in-vitro diagnostic device function 

• Lateral flow device experience is plus. 

• Ability to read, interpret and understand technical and non-technical documents including product drawings, specifications, contracts and purchase orders 

• Experienced in root cause analysis and corrective action processes. 

• Working understanding of regulations relating to in-vitro diagnostic medical device products (e.g. 21CFR Part820, EN ISO 13485, EN ISO 14971:2012, CMDR). 

• Must be able to work independently 

• Experience with 21 CFR 820.50. 

• Excellent analytical skills. 

• Excellent written and verbal communication skills 

• Must be organized and detail oriented 

• Must be able to work independently 

• Attention to detail, including thorough documentation of activities. 

• Working knowledge of process validation and design control. 

• Proficiency with Microsoft Office, Word, Visio and Excel. 

• ASQ Certified Quality Engineer or equivalent experience desired 

• Ability to travel approximately 15 to 20% domestic and international. 

• Must be able to demonstrate the ability to be a part of a team (e.g. Procurement, Manufacturing, R&D, Quality and Working with site leadership team). 

• Must be able to step out of their comfort zone to help other members of the team at a moment’s notice.
 
 
 
 
 
 
 
 
EEO Employer
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 844-463-6178-6178.