Principal Clinical Quality Specialist

JOB TYPE: Full Time, Employee JOB CATEGORY: Biotech/R&D/Science CITY: Minneapolis STATE: MNAbout Medtronic Benefits and Total Rewards It's challenging. It's energizing. It's rewarding. That's why our nearly 38,000 employees have chosen to spend their careers at Medtronic, a global leader in medical technology, providing lifelong solutions for people with chronic disease. Today, every 5 seconds the life of someone somewhere in the world is improved by a Medtronic product or therapy. Join us in our mission to alleviate pain, restore health and extend life, and discover why FORTUNE magazine named us one of the "100 Best Companies to Work For" eight of the last 10 years. Principal Clinical Quality Specialist Req. # 59951Position Description The Principal Clinical Quality Specialist is responsible for assuring that clinical personnel across Neuromodulation are educated in, and operating within, U.S. and international regulatory requirements and Medtronic standards, and facilitating continuous process improvements. This will be accomplished through bringing the clinical organizations into a quality systems model of operation that will bring improved business processes and ensure that quality is built into the clinical process. The Principal Clinical Quality Specialist works without appreciable direction and exercises considerable latitude in determining objectives of assignment(s) and compliance-orientated solutions to a wide range of difficult problems. These solutions require regular use of ingenuity, influence management skills and creativity.  Completed work is reviewed from a relatively long-term perspective, for desired results. The Principal Clinical Quality Specialist may provide guidance to lower level personnel. This position requires extensive knowledge of clinical research (both device and pharma) and quality regulatory requirements, and other related disciplines. Position Responsibilities Performs the following tasks:• Analyzes the organization for systematic proactive improvement opportunities by planning and leading audits of clinical studies; reviews CAPAs to audit findings and resolves issues pertaining to CAPA responses; develops audit reports• Seeks out guest auditors and provides training ( as required)• Provides training and education to clinical personnel to enable multiple resources within the organization to support clinical centers with regulatory inspections and/or Corporate Audits; Assist clinical study teams/centers in preparation and/or during regulatory inspections• Develops or revises SOPs and associated documentation to support audits activities• Acts as an advisor on clinical quality assurance issues such as informed consent, device accountability, clinical investigational plans, and document control Basic Qualifications Bachelor’s degree (technical or non-technical) Job Experience: 9-13 years experience (or 7-11 years with an M.S. Degree) directly supporting clinical research within a regulated environment, or other relevant quality or audit experience in a regulated environment. Desired/Preferred Qualifications Skills/Competencies: High attention to detail and accuracy Able to manage multiple tasks Proficient knowledge in FDA and international regulations (pharmaceutical and/or device) and/or experience in Quality Systems regulations Strong interpersonal skills, ability to work with teams and be a self-initiator Physical Job Requirements Ability to travel 20 to 40%   To Apply: Click Apply Now to route your resume directly to the hiring department. No agencies or phone calls, Please Medtronic is an euqal opportunity employer committed to cultural diversity in the workforce. www.medtronic.com/employment   Click here to see other Medtronic opportunities  Email this Job to a Friend