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 fingersticks.
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 Compliance Engineer.
WHAT YOU’LL DO
Job Description
The Senior Compliance Engineer provides direction and leadership from within the Quality Systems group to R&D, Quality, Operations and Regulatory Affairs, to ensure the Quality System works optimally and complies with global external regulations and standards.
The position maintains and improves Cardiac Rhythm Management (CRM) Quality System and supports the execution of key Quality System processes such as audits, CAPA, training, change management and management review.
Main Responsibilities
The Compliance Engineer ensures that the division main quality systems are properly supported to ensure regulatory compliance. This position also ensures optimization of the QS to make more efficient the product realization.
Lead planning and execution of internal and external audits.
Assess and continually improve the areas of training, change management and CAPA processes.
Support the management review process to ensure management responsibility commitments are met.
Assess the compliance of CRM processes and product portfolio against applicable regulations and standards.
Facilitate CAPA process by providing subject matter expertise, evaluating adequacy of investigations and actions taken against established criteria, and assisting in the completion of CAPA projects in order to ensure process compliance and record quality.
Monitors compliance of company policies and procedures with regulatory requirements (e.g. compliance with FDA, ISO 13485, EUMDR, TGA, Anvisa, PMDA, NMPA, and emerging market regulations and standards etc).
Monitor external sources of information to identify applicable regulations and standards and determine necessity of company product conformity.
Support internal and external audits as subject matter expert for sustaining state of the art conformity during the product lifecycle.
The position serves a strategic purpose for Abbott and must achieve a balance of involvement and objectivity,
Demonstrate appropriate risk-based decision making, and prioritize key activities to maintain product conformity and GMP/QMS compliance.
The position also provides an active role within the Corporation as Divisional experts in external regulatory requirements and applicable standards.
Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements
As appropriate, participates in or leads teams in supporting quality disciplines, decisions, and practices (e.g., represent the Quality System function as a Team Member)
EDUCATION/EXPERIENCE YOU’LL BRING:
Bachelors Degree and 5+ years of related work experience with a strong understanding of specified functional area, an equivalent combination of education and work experience
- Medical Devices/Pharma experience is required
- CAPA experience is required
- Experience working with standards/regulations
Wide application of technical principles, practices, and procedures. Strong understanding of business unit function and cross group dependencies/ relationships. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
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.