Senior Compliance Engineer
Position: Senior Compliance Engineer
Location: Sylmar, CA
Posted: June 21, 2021
WHAT YOU'LL DO
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.
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.
CRM Cardiac Rhythm Management
United States > Sylmar : 13150 Telfair Avenue
Yes, 10 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Posted 30+ Days Ago
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.