HireDiversity

Menlo Park, CA, US

SR SPECIALIST, QUALITY ASSURANCE-8880130117

Description

Acclarent, Inc., a member of Johnson & Johnson's Family of Companies, is currently recruiting for a Senior Specialist - Quality Assurance located in Menlo Park, CA.

Acclarent, Inc. is a medical device company in Menlo Park, CA that was established in June of 2004. The company is dedicated to the development of innovative devices providing new technologies to further meet the needs of ENT patients.

Acclarent's initial focus is on achieving the goals of sinus surgery with novel, endoscopic, catheter-based tools - Balloon Sinuplasty™ devices. Through the Balloon Sinuplasty™ technology and our Relieva® product portfolio we offer ENT patients another option to conventional endoscopic surgical technologies. FDA clearances for these devices were completed in 2005 and the products were commercially launched in the US that same year.

Through our core technologies and commitment to innovation, Acclarent will continue to advance novel devices in all areas of ENT.

The Senior Specialist - Quality Assurance will be responsible for facilitating DCO/ECO Change Approvals, via the document control database, as well as administrate associated training requests. This position is also responsible for the day-to-day administration of Arena, including resetting user passwords, and adding new users to the database, and training employees regarding database usage. Will also schedule database maintenance activities and generate reports and metrics required to monitor the document/change control system. This role is the organization's primary resource for the timely filing and retrieval of quality systems records. In this capacity the incumbent must keep accurate records of control quality records, and administrate the archiving and off-site storage of records. Responsibilities will also include efficiency improvements.

This role will also participate and/or lead initiatives in other areas of Quality Systems such as CAPAs, Internal Audits, and overall Compliance.

Qualifications


A minimum of a Bachelor's degree is required and a BS in a technical field is preferred. A minimum of 5 years experience in Document Control and Quality Systems (CAPAs, Internal Audits, Compliance, etc.) is required, preferably in a medical device manufacturing environment. Supervisory experience is preferred. Strong problem solving, superior time management, demonstrated ability to manage multiple tasks and excellent communication skills are required. Thorough knowledge of medical device GMPs and ISO standards applicable to the FDA and international regulatory agencies is strongly preferred. Must be competent in computer skills and possess the ability to work quickly within an electronic document control database (e.g. Arena). Must be competent and knowledgeable in using Microsoft Office Suite. Expertise in Excel is particularly desired. Experience in other quality systems (CAPA, Internal Audits, Compliance) is required. Must be able to work quickly and accurately in an electronic or web based database environment.

This position will be based in Menlo Park, CA

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

Primary Location:North America-United States-California-Menlo Park
Organization: Acclarent, Inc. (6206)