Quality Manager

Job Purpose:

Responsible for the implementation and maintenance of the WorldHeart Quality System in the Salt Lake City facility.  Responsible for the oversight and management of all associated Quality activities including Quality Control, Quality Engineering and Documentation.

Essential Duties & Responsibilities:Implement and maintain Quality System processes/procedures.Ensure that product and process documentation is appropriate and adequate for WorldHeart and it's suppliers and subcontractors.  Administer the Documentation/Quality Records function including oversight of the generation and maintenance of Design History Files, Device Master Records, Device History Files and applicable Quality records.Review and evaluate Engineering Change Orders to determine the impact of design, material, or process changes on product and/or process validations and Quality Control requirements/processes.Participate as Quality representative on Design Control Project team(s) to facilitate product development to include but not limited to the development and approval of hazard analyses and FMECAs, and the review and approval of test plans and protocols.Facilitate internal, external and supplier audits including timely analysis and resolution of any findings resulting from those activities.Administer/oversight of the calibration program.Provide Quality Engineering support to Materials/Procurement to ensure timely analysis and resolution of supplier related issues.  This will include participation in the selection and approval of qualified suppliers.Participate in the development and performance of regularly scheduled quality trend reviews.  Prepare and present manufacturing quality data reports, including process trend analysis to executive management at regularly scheduled Management Review meetings.Direct and coordinate the activities of the Quality department personnel in Salt Lake City.Perform and/or assist in the training and supervision of personnel to assure that established processes and activities are performed correctly.Participate in the set-up, validation, operation and ongoing monitoring of the manufacturing facility.Perform any additional assigned jobs as directed.

Education and Experience:Bachelor's degree or equivalent in scientific or technical discipline.5 to 10 years experience in the medical device industry required, preferably with Class III medical devices.Thorough knowledge and understanding of the principles, concepts and theories of FDA QSR, CFRs and ISO 13485.

Skills:Excellent written and verbal communication skills.Computer literacy, including database experience with Microsoft Access or equivalent is required.Strong leadership and interpersonal skills.Firm commitment to quality output and internal & external customer satisfaction are essential.