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.
About Abbott
For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, CA, currently has an opportunity for a Senior Quality Compliance Specialist.
WHAT YOU’LL DO
- Plan, perform, support and document QMS compliance audits as certified lead auditor or team member. These audits must be tracked to standards and regulations.
- Manage the tracking of the Audit CAPA corrective actions. Complete Audit CAPA investigations as owner.
- Develop and maintain internal audit checklists and tools.
- Support internal and external team Sharepoint sites.
- Maintain internal audit compliance files.
- Follow up on internal and external audit observations and actions.
- Update compliance team documents and procedures, as requested.
- Support divisional quality and compliance initiatives, goals, and metrics.
- Assist and support customer and external audits, as requested.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Perform specialty audits, as requested by management.
- Mentor compliance and quality team members.
- Performs other related duties and responsibilities, on occasion, as assigned.
EDUCATION AND EXPERIENCE YOU’LL BRING
- Bachelor’s degree or equivalent work experience
- A minimum of 5+ years of related work experience in medical devices or other FDA-regulated industry is required. Incumbent must have extensive experience on performing internal audits, managing external inspections/responses and be proficient in CAPA processes.
- Any professional Quality System related certification is strongly preferred (i.e. ASQ Quality Auditor, ASQ Quality Engineer, ASQ Biomedical Auditor, or equivalent).
- Experience working in a broader enterprise/cross-division business unit model preferred.
- Ability to work in a highly matrixed and geographically diverse business environment.
- Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
- Ability to leverage and/or engage others to accomplish projects.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Multitasks, prioritizes and meets deadlines in timely manner.
- Strong organizational and follow-up skills, as well as attention to detail.
- Ability to travel approximately 15-20%, including internationally.
- Ability to maintain regular and predictable attendance.
WHAT WE OFFER
- At Abbott, you can have a good job that can grow into a great career. We offer:
- 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: www.abbottbenefits.com
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 www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.