| Company profile |
| Founded in 1981, Atrium is a privately held healthcare products company located in Hudson, NH. Atrium is a market leading manufacturer of breakthrough medical device technologies used in open heart surgery, emergency chest trauma, thoracic drainage and surgical repair of diseased blood vessels. More recently, Atrium is known for its high technology presence in coronary stents, minimally invasive intervention of peripheral blood vessels, state-of-the-art hernia repair, drug delivery research, hemodialysis access, and market leadership in facial plastic surgery. Atrium manufactures over 1,000,000 sterile medical products each year which are distributed to over 60 countries. Maintaining a commitment to innovation in research, market development and manufacturing has enabled the company to excel in many global medical device markets. With more than two decades of experience, Atrium has been an innovator of new technologies designed to meet the clinical needs of the patient. Whether it is chest drainage, drug delivery, drug coated stents, or new ways to deal with vascular disease and general surgery, Atrium is working on a new and innovative ways to solve unmet clinical needs. Atrium offers a unique opportunity with exciting challenges for the qualified candidate. |
| Job details | |
| Job industry : | Biotechnology/Pharmaceutical |
| Job segment : | General |
| Job role : | Other |
| Job skill : | Specialist |
| Position vacant : | QA Specialist |
| Job location : | Hudson, New Hampshire |
| Job code : | QA-BD |
| Job details | |
| Company name : | Atrium Medical |
| Minimum experience : | 3 years |
| Maximum experience : | 7 years |
| Job type : | Permanent |
| Gross pay : | Negotiable for the right candidate |
| Job posted : | Aug 31, 2006 |
| Start date : | Sep 03, 2006 |
| Job view count : | 462 |
| Job description | |
| Job description: | Position Specific Requirements:
Maintains regulatory compliance and maintenance of the quality system, monitor sources of regulatory information for new or revised regulations, directives, standards and create/update standard operating procedures. Reponsible for maintenance and tracking of Returned Goods Authorization (RGA) information. Responsible for review and follow up of customer complaints in accordance with procedures, and file Medical Device Reports (MDRs) and/or comparable reports as required. Partner with Product Managers to facilitate evaluation of customer complaint and/or returned goods. Perform internal audits as member of the audit team; perform audit follow ups and assist with special audit projects. Develops standard operating procedures and corporate quality and regulatory policies. Facilitate proper notifications of discrepancies (OOS and Deviation report. Perform data collection for annual reporting and other trending as required. Independently perform domestic and international product registration support activities. Coordinates quarterly product testing, environmental testing/monitoring and biocompatibility testing required for new and existing product development projects. Provide guidance documents and guidelines to R&D, Regulatory Affairs, Pre-Clinical, Clinical and other areas as needed. Perform other duties as required. Qualifications: BA/BS with three plus years experience working in regulatory affairs, compliance or quality assurance. Computer proficiency including MS Office, Outlook, Excel and PowerPoint (presentations and slideshows). Oracle experience preferred. Excellent written and verbal communication skills. Strong customer service focused work ethic and skills. Demonstration of strong writing, editing and proofreading skills. Proficient attention to detail. Professional interpersonal skills necessary to interact with external customers and internal contacts. Demonstrated time management and organizational skills; ability to work independently and as part of a team required. |
| How to apply : | Register to view |
| Third party mediation allowed : | No |
| Telecommute : | No |
| Travel required : | No |
