Quality Assurance Director

ArthroCare Corp. (Nasdaq:ARTC) is a multi-business medical device company that develops products based on its pioneering Coblation(R) technology. This position will report directly to the CTO. The benefits of Coblation technology provide an answer to the challenges of soft tissue management in any surgical specialty where controlled and efficient ablation is of value. Current applications include: Arthroscopic surgery, Spine surgery, Dermatologic surgery, Ear, nose & throat surgery (ENT), and General surgery.

Our greatest achievements come from our greatest assets: ArthroCare's employees. We are continuously seeking new talent to join ArthroCare's winning ranks. People who thrive at ArthroCare are passionate about improving surgical procedures and patient outcomes, have a competitive spirit and winning attitude, and place a high value on teamwork and trust. We offer a competitive benefits package and excellent opportunity for career development.

We currently have an opportunity for a POSITION TITLE to join us! SUMMARY FROM JOB DESCRIPTION.

Implement, support, and sustain elements of ArthroCare’s quality system through procedure generation, training, auditing, document control, supplier assessment, and technical support. Directs compliance efforts through out ArthroCare’s facilities. The Director, QS and Compliance serves as a key resource for ISO, EN, MDD, and QSR requirements. Serves as the Management Representative.


Essential Duties and Responsibilities include but are not limited to:
*Ensures implementation and compliance of the ArthroCare Quality System to FDA QSRs, MDD, ISO 13485:2003 and other relevant international regulations.
*Assigns resources to support company quality initiatives.
*Evaluates quality system elements using tools such as auditing, corrective/preventive action, training, and trending. Initiate improvements as needed.
*Directs supplier assessment and supplier quality functions.
*Collaborate with engineering, manufacturing, and regulatory, and work with outside labs and suppliers.
*Ensure that compliance to cGMP and EN/ISO 13485:2003 /MDD/Canadian and other international regulations and standards are maintained.
*Ensure that all the responsibilities within the scope of this job comply with the scope of the ArthroCare Quality System.
*Serve as the Management Representative for the corporation.
*Oversee internal and external audits and assessments.
*Manage the Document Control and Supplier Quality functions.
REQUIREMENTS
Qualifications:

*Requires a bachelor’s degree in engineering or life sciences and 8 to 10 years experience, or an AA and equivalent work experience totaling more than 12 years in the medical device industry. Master's degree in Quality or Business preferred.
*Requires 5 to 7 years of management experience.
*Must be able to make decisions related to product quality and release of ArthroCare products.
*Requires ability to assess current ArthroCare practice with external standards, guidance, and regulations.
*Must be a team player.
§Must be able to provide and implement solutions to quality problems.
*Requires the ability to understand the impact of GMP’s, ISO 13485:2003, Canadian, Japanese and other international standards, and MDD requirements on ArthroCare products


For consideration of this and other opportunities please visit our career center at:

http://careers.arthrocare.com

Equal Opportunity Employer
www.ArthroCare.com