Manager Quality Systems Compliance (IRC7149)
Location: Plainsboro New Jersey
Description: Integra LifeSciences is in need of Manager Quality Systems Compliance (IRC7149) right now, this vacancy will be placed in New Jersey. For detail informations about this vacancy opportunity please read the description below. Integra LifeSciences Holdings Corporation, a world leader in regenerative medicine, is a global medical device company dedicated to improving the quality of life for millions of patients every year. Our products are used primarily in orthopedics, neurosurgery and general surgery . We are a leader in applying the principles of biotechnology to medical devices, particularly for neurosurgery and extremity reconstruction, and are one of the largest surgical instrument companies in the U.S. Headquartered in Plainsboro, New Jersey, Integra has research and manufacturing facilities throughout the world.
Integra has been repeatedly named as one of Forbes 200 Best Small Companies and was listed as one of New Jersey' s 50 Fastest Growing Companies by NJBIZ in 2009. We were also selected as one of the Medical Device Manufacturers of the Year by Medical Device & Diagnostic Industry Magazine in 2007. We value innovative thinkers who are open to new opportunities. We are looking for self-motivated people who like being challenged and derive satisfaction from knowing that their efforts are making a difference in someone's life. Detailed Description Responsible for the monitoring of Quality System Compliance and effectiveness evaluation for the Companies of Integra LifeSciences. Assess against and implement Corporate policies and company compliance procedures consistent with the requirements of the Food and Drug Administration, International Standards of ISO 9001, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations ( CMDR ), Japanese QMS Ordinance (Ministerial Ordinance No 169), Australian Therapeutic Goods (Medical Devices) Regulations and all other applicable regulatory agencies.
The primary responsibility of the Manager, Quality Systems Compliance is to provide assessment of the Companies of Integra LifeSciences in relation to conformance with national and international governmental quality system regulations and to assist the companies of Integra LifeSciences in maintaining full compliance with these regulations and with all Integra Corporate quality policies. Execution against Corporate QS audit program. Track and Trend key compliance issues from Corporate audit program and/or corrective actions at each location. Monitor key indicators of Quality System at each site for corrective and preventative action changes. Coordinate with Vice President of Quality Systems all ISO audits, FDA inspections and visits, and all communications with Notified Bodies regarding audit issues. Provide technical assessment for due diligence assessment for potential acquisitions, business partners or critical suppliers. Integrate company acquisitions as appropriate into the Integra LifeSciences quality system or ensure their Quality System is in compliance with the regulations. Assist in preparation for sites with scheduled ISO or FDA audits. Act as independent reviewer for Design Control program where necessary. Monitor and contribute to development and implementation of training programs for Corporate departments and operating companies as needed. Maintain up to date understanding of all issues and changes in regulatory compliance activities at FDA, European Economic Area, Japan and Rest of World compliance groups. Contribute to the Corporate Document Management Process , HHE, CAPA, Complaint and Change Control issues and initiatives. Performs all other related duties as required. Job Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Any equivalent combination of education and experience that provides the applicant with the knowledge, skills, and abilities to perform this job is acceptable. Individual should have in depth experience in one or more of the following areas: aseptic process, statistics, sterilization (EtO, Gamma), process validation, GMP/technical training, auditor certification, project management.
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How To Apply We are committed to creating an environment where all employees are valued and respected. We offer a competitive benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement, and employee stock purchase plan. To find out more about our company, visit our website at: http://www.integra-ls.com/home/careers/ No Agencies. LOCAL CANDIDATES ONLY PLEASE. EOE, M/F, D/V Integra is not currently accepting unsolicited assistance or resumes from search firms for this employment opportunity. All resumes submitted by search firms or agencies to Integra or its employees, agents, directors or representatives in any form or method without a valid written agreement covering this position will be deemed the sole property of Integra. No fee shall be paid in the event the candidate is hired by Integra as a result of the referral or through other means. Search firms are essential to the recruitment and staffing efforts at Integra and we value the partnerships we have built with our preferred vendors. For this reason, Integra has established and regularly maintains a vendor list. Please note that even preferred vendors are required to have a written search agreement signed by an authorized signatory of Integra in order for a fee to be paid for any candidate referrals.
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If you were eligible to this vacancy, please email us your resume, with salary requirements and a resume to Integra LifeSciences.
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This vacancy starts available on: Thu, 02 Aug 2012 15:52:14 GMT