CAPA/COMPLAINT ARCHITECT (MEDICAL DEVICE EXPERIENCE REQUIRED)
Chatsworth, CA

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Adecco Engineering and Technical, a division of the world leader in the recruitment of engineering and information technology professionals, has an immediate opening for a CAPA/Complaint Architect on a contract job opportunity with a leading renowned, multinational company at Chatsworth, CA.

Job Description:
This is a long term temporary position for a CAPA/Complaint Architect with responsibility for defining and managing core Quality System functions in the areas of Corrections and Removals, Corrective and Preventive Actions and Complaint Handling. This position includes deployment of processes to employees, updates to records and process document revisions.

It is critical that the candidate has prior medical device complaint handling department and experience with CAPA’s. In need of someone who has written or improved the governing processes or “Standard Operating Procedures” (SOP’s) for complaint handling and CAPA.

Responsibilities:
The successful candidate will need to demonstrate expertise in the following areas:
  • Provide coordination, review and dissemination of Corrections & Removals documentation (customer information letters, field safety notifications, communications with distributors, etc). This position includes deployment of processes, oversight and monitoring of field actions.
  • Lead Corrective and Preventive Action (CAPA) process optimization. Focus will be to define and implement process changes as needed and train employees on the use of the improved processes. Beneficial to be knowledgeable in CAPA investigation techniques, including Failure Modes Effects Analysis (FMEA) and performing risk analysis relative to ISO 14971.
  • Lead Complaint Handling and customer feedback data collection and analysis. Define methods, analysis and reports for Quality Monitoring utilizing field returns, manufacturing test results and other information to understand and correct design, manufacturing, and user-related problems. Knowledge of MDR, MDV, MDB and other country Incident Reporting requirements is beneficial.
  • In addition, the person holding this position will support Quality System process updates, records retention and storage and training record updates.
Requirements:
The successful candidate will possess the following knowledge, skills education and experience:
  • Required – 5+ years experience in a medical device, pharmaceutical or healthcare industry
  • Required – Bachelor Degree (Science, Engineering or similar technical discipline)
  • Required – 3+ years experience in medical device regulations and standards (specifically FDA Medical Device regulations (QSR) requirements, ISO13485 and applicable Medical Device Directives).
  • Experience in addressing Corrections and Removals, Corrective and Preventive Actions and Complaint Handling in a regulated industry. Beneficial to also have Incident Reporting experience.
  • Demonstrated competence in performing effective troubleshooting. Excellent problem solving skills (root cause analysis).
  • Must be well-organized, able to function with minimal supervision and able to meet deadlines.
  • Ability to communicate effectively.
  • Proficiency in database searches (such as ERP systems) and the use of the Microsoft Office suite, particularly Excel.
If you are interested in this opportunity or other opportunities available through Adecco Engineering and Technical, please apply online or email directly to sunetra.sen@adeccona.com.

The Adecco Group is a Fortune Global 500 company and the global leader in HR services. Our group connects over 700,000 associates with our business clients each day through our 6,600 offices in over 70 countries and territories around the world. We offer employment opportunities at any stage in your professional career. Contact us today to discuss available contract and direct hire positions. Adecco Engineering and Technical offers benefits including Holiday, 401(k), Insurance Benefit Plans and Anniversary Bonus opportunities. Adecco Engineering and Technical is an Equal Opportunity Employer.

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