This position performs all functions of the Quality department in Canada and work as part of the North American Quality and Regulatory organization to achieve the company objectives of safety, quality, efficiency, productivity, customer service, and regulatory compliance.
Principal Job Duties & Responsibilities:
Review quality problems with appropriate personnel and direct action required for correcting defects. Provide communication link between operations, product management, customer and technical service to develop inspection guidelines and quality system procedures.
Manage sampling inspection and testing of received parts, components and materials to determine conformance to standards. Work with suppliers on quality improvement initiatives.
Work cooperatively with Quality leads in all SRM facilities globally for consistency of process and on-going continuous improvement activities.
Provide various types of Quality Assurance and Regulatory Affairs analysis and reporting at determined intervals and as requested.
Bachelor’s degree from a four year college or university required; minimum of five years of quality/engineering related experience and/or training.
ASQ Quality Management certification and Six Sigma certification preferred. Internal Auditor certification is a plus.
A Regulatory Affairs Professional Society [RAPS] Regulatory Affairs Certification [RAC] is desirable.
Highly motivated and self-sufficient with a strong work ethic and the ability to work independently without daily supervision and/or direction is required.
Ability to read, analyze and interpret journals, engineering blueprints and drawings, and governmental regulations. Ability to write reports and effectively present information.
Ability to work with mathematical concepts. Ability to solve practical and complex problems of a technical nature and deal with a variety of concrete variables in situations where only limited standardization exists.
Strong process-development, training and presentation skills.
Hands on experience in diagnosing, troubleshooting, problem solving.
Fluent in Microsoft Office applications (PowerPoint, Word, Excel) and working knowledge of internet (Microsoft Explorer) functions.
Sunrise Medical is a world leader in the development, design, manufacture and distribution of manual wheelchairs, powered wheelchairs, and both standard and customized seating and positioning systems. Sunrise Medical manufactures products in our own facilities in the United States, Mexico, United Kingdom, Germany, Spain, Canada and China.
Our key products, marketed under the QUICKIE, ZIPPIE, B...REEZY, EZ ACCESS, BIO CLINIC, HOYER, BREEZY EVERYDAY, and JAY proprietary brands, are sold through a network of authorized dealers or distributors in over 130 countries. Sunrise Medical's headquarters are based in Malsch, Germany; with North American headquarters in Fresno, California. We employ 1,800 associates worldwide.