Qualtiy Control Team Leader

 

Integra LifeSciences Corporation is a world leader in developing and marketing high quality surgical instruments, as well as innovative devices and products for use in neurosurgery, reconstructive surgery, general surgery and soft tissue repair. In 2006, Integra grew revenues by more than 50% and surpassed $1 billon in market capitalization. We anticipate our significant growth to continue. In 2005 and 2006 Integra LifeSciences was named to the Forbes 200 Best Small Companies list, and has recently been named 2007 Medical Device Manufacturer of the Year by Medical Device & Diagnostic Industry Magazine.  Our rapidly growing company of over 2500 employees is currently seeking a Quality Control Team Leader committed to taking us to even higher levels of growth and innovation.  This position is located at our Integra Pain Management site, in Salt Lake City, UT.

 

SUMMARY DESCRIPTION

Provide Plant Quality compliance support for the following Quality tasks and duties:  Perform In-Process  and Final Inspections and assist in the introduction of new or improved processes.  Act as a member of problem solving teams. Write and coordinate efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as product and material specifications and SOPs.  Facilitate and assist the development, implementation and monitoring of quality programs and policies that ensure that the development, manufacture and distribution of medical products in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485:2003, the Medical Device Directive, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

 

ESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

· Write and help coordinate efforts for the development and implementation of new and updated Quality System procedures for ISO/QSR, such as validation protocols, product and material specifications, SOPs and development projects.

· Help develop statistically based sampling plans for in-process and final testing and inspections, and validations.

· Assist in the preparation of information for Management Reviews, Internal and Vendor Audits, Complaint Investigations, and Corrective Actions.

· Ensure that all projects are in compliance with GLP, QSR, ISO or other applicable requirements.

· Provide support in FDA inspections, ISO Certification and surveillance audits and customer audits.

· Help to identify and implement opportunities for continuous improvement.

· Interact and coordinate activities with other departments.

· Perform other related duties as required. DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

· 2 - 5 years experience or equivalent combination of education and experience in the medical device or pharmaceutical industry.

· Demonstrates excellent knowledge of AQL sampling, including In-process and Final QA inspections.

· Demonstrates excellent organizational and communication skills and proficiency with MS Word and Excel.

 

 

We are committed to creating an environment where all employees are valued and respected. We offer a competitive compensation/benefits package including 401(K) savings plan with match, medical, vision, dental, life insurance, tuition reimbursement and employee stock purchase plan. Please forward all resumes and salary requirements to: integrastaffingNF@integra-ls.com Please state Corporate Counsel in the subject line.

Website. http://www.integra-ls.com  Local candidates preferred. No agencies please. EOE, M/F, D/V