US-UT-Salt Lake: Quality Assurance Engineer Supervisor

To see other opportunities, please visit http://sqa.fyicenter.com
Date: 18-Jul-2008

Quality Assurance Engineer Supervisor

# Responsibilities: Provide Quality Engineering support to Manufacturing, Quality & Regulatory and Process Development teams to ensure that products are manufactured with a high level of quality, while being in compliance with regulations governing medical devices manufacturing. # Serve as technical quality leader and provide guidance in support of significant or chronic process or product investigations. # Utilize process validation methodologies, IQ/OQ/PQ to ensure that new product / process and changes are robustly transferred to production, partner / mentor QA Technicians to facilitate continuous improvement efforts on production floor. # Generate, interpret and present reports on quality and product complaints to internal product improvement teams and for corporate reporting. # Manage and oversee the divisions Change Notice process; setting priority in accordance w/ business needs, allocating resources to complete tasks, and providing regular reports on progress, problems, needs, etc, to management team. # Support the implementation of quality improvement programs. # Review and approval of procedures, technical / validation reports, change notices, and non-conforming material reports. # Develop and implement manufacturing process monitoring systems to evaluate product quality. # Facilitate and administer delivery holds, participate on internal audit team in conducting internal quality system audits.

Requirements: # BS in Electrical/ Mechanical Engineering or science discipline or equivalent. # Minimum of 5 years experience in medical device industry, demonstrated understanding of, and ability to interpret regulations and guidelines governing medical device development, including CFRs, ISO 9000, EN 46001, and the MDD. # Demonstrated understanding and experience in applying modern quality assurance and control tools (statistical analysis, acceptance sampling, DOE, gauging and gauge R&R, Statistical Process Control). # Strong working knowledge of process development and validation methodologies (IQ,OQ,PQ), willingness to work as a team player in a change oriented department. # Demonstrated ability to manage/coordinate investigations and continuous improvement projects # Experience interacting directly with suppliers, Manufacturing, and Manufacturing support organizations preferred. # Excellent technical writing, communication, and organizational skills required, experience with MS Office products required, experience with a statistical software package is a plus, ASQ Certified Quality Engineer is a plus, Six Sigma Black Belt is a Plus. # Excellent oral and written communication and interpersonal skills, ability to work independently and complete multiple assignments on time, required. # Demonstrated understanding and experience in applying modern quality engineering and management concepts such as Six Sigma, Process capability Analysis, Risk Assessment, PFMEA and DFMEA. # Supervisory experience for small team of technicians and Engineers is a plus

For more information, please write to us.

Thank you,
Team SQAFYI - Software QA Resource FYI
http://sqa.fyicenter.com