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Quality Specialist
Ref No.: 18-06616
Location: Irvine, California
Position Type:Full Time/Contract
Start Date / End Date: 09/10/2018 to 09/10/2019
To perform compliance activities that ensure required quality and safety standards are being met for our products.
Perform compliance activities of complex nature as per schedule and per standards/SOPs.
Develop your knowledge to become a SME to the compliance team on topics such as: GMPs, Compliance Activities, Record Retention, Audit, Gap Assessment, Regulatory documentation (Certificates), and the Alcon Quality Manual.
Develop a high level of integrity and have a desire to comply with regulations and standards.
Approve, review, and provide meaningful actionable feedback on projects, metrics and documentation.
Write and take ownership for compliance SOPs.
Participate in external (Health Authority, Notified Body) and internal audits as required.

Knowledge of cGMP regulations for medical device manufacturing operations and validation procedures and practices.
Exhibits sound judgment by evaluating problems thoroughly, soliciting input and ideas, and using a systematic decision making approach.
Appropriately challenges the status quo and uses knowledge and experience to continuously improve work processes.
Possess understanding of the relationships between Manufacturing, Quality Assurance, Compliance, R & D and Regulatory Affairs.