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For your reference, we have included the original job posting below.
Field Assurance Manager
Job Number:
25737295
Company Name:
C. R. Bard
Job Location:
Lowell, MA US
Job Category:
Healthcare & Medical
Field Assurance Manager
Field Assurance Manager
/Category:, Job ID:, Standard Title:, Career Level:, Location/Division:, Relocation:, Posted Date:, Close Date:">
Industry Title /Category: Medical Device / Field Assurance Job ID: 2010-4435
Standard Title: Field Assurance Manager Career Level: experienced
Location/Division: Lowell, MA / BEP Relocation: No
Posted Date: 7/23/2010 Close Date: ..
C. R. Bard, Inc. (NYSE: BCR)is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 11,000 people in over 25 countries around the world. Founded more than 100 years ago, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees - on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded.
Be Your Best at Bard - and ultimately, you can have an impact on the lives of people around the world.
Apply for this position * Refer a friend to this job More information about this job:
Overview: The Field Assurance Manager has a clear understanding of all product complaint handling processes as well as required regulatory reporting procedures for domestic and international products.
Receives Direction From: VP Quality Assurance
Provides Direction To: Field Assurance Coordinator
Summary of Position with General Responsibilities: Examples of Essential Functions: Including but not limited to: . Maintain the Standard Operating Procedures in accordance with the FDA/MDD (Medical Device Directive) rules and regulations of maintaining procedures for receiving, reviewing, and evaluating complaints. . Submit and write Medical Device Reports and Vigilance Reports to FDA and Notified Bodies. . Interface with distributors, sales force, international representatives, and in-house departments for complaint information. . Monitor receipt, processing, and closure of product complaint files, maintaining complaint files and database. . Oversee the investigation of returned devices. Monitor the receipt of the investigation findings, recommend corrective actions if necessary and follow up on all corrective actions. . Work with other departments to complete corrective actions and other product issues. . Assist in Corporate and Internal Audits. . Coordinates customer responses to complaints;. . Manage Product recalls and field actions. . Manage database for in-process quality report and compiling monthly/quarterly quality reports.
Basic Qualifications: Any combination equivalent to, but not limited to, the following:
Education/Training/Experience: College Degree in Science or Clinical
Nursing preferred. Medical professional strongly preferred. Five to ten years experience in similar quality assurance activities in the medical device industry.
Knowledge of clinical practices, FDA and ISO Quality Requirements, and Medical Device Reporting..
Knowledge/Skills/Abilities: Basic reading and math; Computer literate; use of word processing, spreadsheets; Recognize problems and take corrective measures; Excellent written and verbal communication skills
Physical Requirements: . Standing, Sitting, Walking, Stairs, . Travel by air, rail, and auto . Evaluating products through a microscope . Working on parts while looking through a microscope
. Manual dexterity; Eye/hand coordination; Computer operation; Light lifting; Direct exposure to health and safety hazards associated with production materials and equipment
