Senior Clinical Quality Associate
Permanent (Full time)
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. Abbott Vascular provides innovative, minimally invasive and cost-effective products for treatment of vascular disease. Our extensive portfolio includes drug-eluting stents, bare metal stents, guide wires, balloon dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents. Our location in Maple Grove, MN, currently has an opportunity for a Senior Clinical Quality Associate. This position could also be based out of our Sylmar, CA or our Santa Clara, CA site. * THIS IS AN IN-HOUSE POSITION - NO REMOTE * NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS POSITION. WHAT YOU'LL DO: Responsible for supporting Global Clinical Affairs personnel globally in ensuring compliance with medical device and GCP regulations and standards, as well as company policies and procedures and other applicable requirements. Responsible for compliance with applicable regulations and standards, as well as Corporate and Divisional Policies and procedures. CAPA * Generate CAPA documentation, including investigations, resolution plans, and implementation reports * Ensure work complies with regulatory and compliance standards * Work cross-functionally to develop pragmatic and compliant solutions for CAPA activities * Drives continuous process improvement * Strong written communication skills Study Support * Review study documents for compliance to applicable regulations, standards, and internal procedures * Act as a resource to clinical study teams regarding compliance to regulations, standards, and Abbott procedures * Support compliant execution of clinical research projects * Preferably has prior experience with GCP regulations and standards, including 21 CFR Parts 50, 54, 56, 812 and ISO 14155 Internal/External Audits * Key player in the preparation and overall support for internal and external audits, including responding to audit findings such as through the CAPA process * May perform internal compliance assessments and/or audits * Support project teams in preparation for regulatory authority inspection or audit, or corporate or divisional regulatory compliance audit * May support other clinical quality tasks as requested and as need arises. Job/Technical Knowledge: * Strong understanding of Good Clinical Practice (GCP) including . regulations and international standards, Quality Assurance/Control, as well as of relevant regulations and procedures * Cooperation/Teamwork: team player with autonomy capable of working independently under minimal supervision * Planning and organizational skills: organizes self in an efficient manner * Problem solving: gathers information before making decisions; weighs alternatives against objectives and arrives at reasonable decisions * Adaptability: remains open-minded; performs a wide variety of tasks and changes focus quickly as demands change * Initiative / Innovation: explores alternative successful ways of working and tools; able to challenge conventional practices; creates novel solutions to problems EDUCATION AND EXPERIENCE YOU'LL BRING: Minimum Education: * Bachelors' Degree (preferably in Life Sciences) or equivalent education and experience. Preferred * Prefer GCP, CAPA, and/or audit experience. * At least 5 years of medical devices, clinical research experience, or related industry. * Prefer at least 3 years of related work experience in Quality role in medical device area and/or clinical trial environment. * Specific requirements * Fluent in English * Strong communication skills * Strong computer skills including Microsoft Office applications WHAT WE OFFER : At Abbott, you can have a good job that can grow into a great career. We offer: * A fast-paced work environment where your safety is our priority * Training and career development, with onboarding programs for new employees and tuition assistance * Financial security through competitive compensation, incentives and retirement plans * Health care and well-being programs including medical, dental, vision, wellness and occupational health programs * Paid time off * 401(k) retirement savings with a generous company match * The stability of a company with a record of strong financial performance and history of being actively involved in local communities * Learn more about our benefits that add real value to your life to help you live fully: * Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. * Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at ###### and on Twitter ###### and ######.