Document Control Administrator at Biolase in Corona, California

Job Description:

 BIOLASE, Inc. is a medical device company that develops, manufactures, markets, and sells laser systems in dentistry and medicine. BIOLASE's products are focused on better enabling clinicians to repair and restore patient's dental conditions while reducing the pain, fear, and anxiety generally associated with dentistry. BIOLASE is committed to elevating the standard of care in dentistry, while enabling clinicians to achieve better business returns.

Job Description

We are currently seeking a Document Control Administrator to be based in Corona, CA.  The Doc Control Administrator role is responsible for several different elements of the Quality System Compliance, Document Control, Change Control Board (CCB) and Internal Auditing.

Document Control

Responsibilities include all related functions within the document control area:

• Process  engineering change orders (ECO) efficiently and in a timely manner


• Identifies nonconforming documents and/or change orders and coordinates correction


• Controls distribution of documents ensuring current revisions are available and obsolete copies are removed


• Managing Training (Under Training matrix)


• Coordinates the activities of the electronic documentation system (Thru Arena and  Great Plains/Teams) to ensure proper compliance, routing, completeness, and accuracy of all documents.

Internal/External Auditing

Responsibilities include conducting and documenting BIOLASE audits, along with evaluating audit findings and monitoring corrective action implementation. This includes coordinating internal audit activities.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Include the following, in addition to other duties assigned:

· Ensure completeness, accuracy and timelines of all document control elements, including Engineering Change Orders and supporting Quality System documentation and records.

· Participate in CCB (Change Control Board) activities and supporting documentation. 

· Conduct and monitor internal audit activities and evaluate audit findings. 

· Support and interface with external auditors, including FDA and Notified Bodies, related to the external audit activities and documentation related to the quality system processes. 

· Interact with other functional groups inside and outside the Quality department.

ADDITIONAL REQUIREMENTS:

· Excellent organizational skills and attention to detail.

· Strong communication skills, both oral and written.

· Ability to prioritize, multi-task and adapt to change.

· Ability to work effectively in a team environment and build strong working relationships.

· High degree of initiative and self- motivation with a strong sense of accountability.

· Strong computer skills in Word Processing, Spreadsheets and Presentation Applications.

EDUCATION and/or EXPERIENCE:

Bachelor’s Degree in technical science discipline, or equivalent to 5 years of experience in the medical device industry related to document control, or other quality assurance / compliance functions. At least 3 years of recent experience in a medical device quality system, or equivalent combination of education and experience. 

BIOLASE is an EOE including disability/veteran

Salary:

$29.00

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