Quality Manager, MDR
Job details Summary Under the direction of the Director of Post Marketing Surveillance, the Quality Manager, MDR provides support and review of Medical Device Reports (MDR’s) being filed with the FDA.
Supervises the review and filing of MDR’s, is responsible for quality related projects associated with post market compliance (retro reviews etc.
), employment and implementation of good manufacturing practices and supervision of Quality Personnel and work flow assigned to the MDR process within the Adverse Event Group. Position overview RESPONSIBILITIES 30% Supervise the MDR process 20% Ensure that MDR review, reporting and filing to FDA to include both initial reports and supplemental materials are completed timely and correctly.
10% Assist in the development and implementation of processes to improve the efficiency and effectiveness of the Adverse Event Group 25% Supervise and carry out quality system projects such as retro reviews and other business specific projects. 10% Develop and mentor associates as applicable reporting to this position permanently or temporarily through projects as well as promote quality system. 5% Fulfill other duties as assigned. May perform other duties as required KNOWLEDGE Comprehensive knowledge of Quality System standards and regulations including 21 CFR 803 & 820, and ISO 13485 / 14971.
Product knowledge -knowledge of product usage & expertise to differentiate between significant and non-significant health risks (to either the patient or health care worker) Knowledge of product failure mode. SKILLS Supervises subordinates and/ or experienced quality system specialist employees who exercise significant latitude and independence. Works well with teams. Excellent oral and writing skills. Expertise to multi-task. Continuous and versatile learner.
QUALIFICATIONS Min BS degree in Science, Engineering, Nursing or other relevant discipline. Min five (five) years or more background Min three years people managerial background preferred Subject Matter Expert in MDR reporting Background working with the FDA, including participation in FDA audits and FDA correspondence. Becton, thinginson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, nice, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or niceual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status.
Location: Sandy, UT
Company: Becton Dickinson & Company