Quality Engineer, West Irvine, CA

Purpose:
Quality Engineer will collaborate closely with business partners to provide support with CAPA activities and documentation to ensure activities are compliant and provide measureable impact to quality, cost, and customer value.

Education/ Experience Required:
BS in a related engineering discipline or other science discipline required
A minimum of 5 years experience is required with at least 3 years medical device experience
Process Excellence experience using Six Sigma methodologies
ASQ certification (e.g., CQA or CQE) or other similar compilation of skills
Proficient computer skills is required, prefer knowledge of MS Office products
Strong knowledge of 21 CFR Part 820, ISO 13485 and familiarity with ISO 14971
Ability to work and communicate in a cross-cultural environment is highly required

Key Job Responsibilities:
Review that all information on the record (this also includes attachments) is correct, accurate, complete, current, and understandable and the record is stand-alone
Review investigation documentation is clear, concise, and robust confirm that an Investigation Summary memorandum has been written
Review that objective evidence exists for all closed all activities and that the objective evidence addresses the nature of the action

All employees shall proactively support ASP's Safety Policy by providing the necessary resources and giving equal emphasis with other functions such as production and quality.

Compliance:
All employees have a duty to comply with applicable laws, regulations, standards, 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, 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