CAPA Medical Device Engineer

Fortune 100 Pharmaceutical Medical Device Company is looking for qualified Professional to work in in the Irvine CA area.

JOB DESCRIPTION                                                                                                                                                                               

PURPOSE: 

Provide CAPA technical expert assessment of current and legacy CAPAs records specifically focusing on thoroughness of root cause investigation and appropriateness of effectiveness check activities according to industry regulations and standards in conjunction with internal procedures.  Project is expected to complete by June 2010.

1. KEY  RESPONSIBILITIES:

·         Perform retrospective classification and expert review of legacy and current CAPAs to prioritize CAPAs and identify issues/gaps within the CAPA phases.  Specifically, root cause investigation and effectiveness check phases according to regulation and industry requirements in conjunction with ASP’s Corrective and Preventive Action procedure SP-05147 and accompanying work instruction.

·         Provide comprehensive weekly reports to containing identified issues or gaps with rationale and recommendations for corrections.

·         [As appropriate and approval of recommendation(s) from ASP Quality Systems Manager], will work with CAPA owners to correct gaps.

·         Will collaborate with Quality Systems Manager throughout the duration of the project.

2.    PHYSICAL DEMANDS:   Walking, standing, and sitting for extended periods.

3.    WORK ENVIRONMENT:  Office environment.

4.    SUPERVISORY RESPONSIBILITIES:  Not applicable.

5.    SAFETY:

All employees including temporary or consultants have a duty to care for their safety and for the safety of others whom may be affected by their acts or omissions at work.  Therefore it is the duty of every employee to:

• Respect and apply safety rules and procedures at all times
• Use personal protective equipment and safety devices as required
• Promote industrial hygiene and safety matters
• Report incidents and damages to management whether injuries are involved or not
• Participate in incident investigation
• Report hazards to management
• Ensure a high standard of housekeeping in the work area
• Be a safety role-model to all employees
• Make suggestions to improve safety at the workplace
• Actively participate in department safety committee

COMPLIANCE:

All employees including temporary or consultants have a duty to comply with applicable laws, regulations, standards, COMPANY policies and ASP policies and procedures.  Examples of required areas of compliance include but are not limited to:

·         Quality Systems (including Product Complaints, Corrective and Preventive Actions (CAPA), Internal Audits, Good Manufacturing Procedures (GMP), and Good Documentation Practices (GDP))

• Sarbanes-Oxley (SOX)
• Health Care Compliance (HCC)
• Government Contract Compliance (GCC)
• Environmental Regulations

·         Records Management

Company Business Conduct and Employee Policies

Job Requirements:

 EDUCATION / EXPERIENCE REQUIRED: 

·         Minimum of a Bachelor’s degree in an engineering or science discipline. 

·         Minimum 10 years experience in working in an FDA regulated industry (e.g., medical devices or pharmaceutical, etc.) with a minimum of 5 years in a CAPA leadership role.

·         Expert knowledge of 21 CFR Part 820 regulatory and ISO 13485 standard CAPA requirements.

·         Exceptional collaborator with excellent communication and writing skills.

·         Possess the ability to work under accelerated timelines to ensure project deliverables are met.