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 Quality Engineer.
WHAT YOU’LL DO
Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced, and progressive. We value people with great ideas who partner with others both internally and externally to take action and accomplish goals.
WHAT YOU’LL DO:
Primary Job Function
Support medical device development and manufacturing operations by ensuring the highest level of quality and compliance for cardiac rhythm management products.
Core Job Responsibilities
* Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments
* Support Company initiatives in support of the Quality Management Systems (QMS)
* Work with design engineering for product design, development, verification, and validation
* Work with microbiology to ensure appropriate environmental monitoring and that microbiology requirements are considered in product and process development activities
* Perform detailed reviews and collaboration on documents & records
* Lead and sustain product risk management
* Identify and implement effective process controls to meet or exceed internal and external requirements, including the development of inspections and test methods
* Lead the investigation, resolution, and prevention of product and process non-conformances
* Appropriately design experiments, document protocols, execute, and report results
* Drive methodologies (e.g. Six Sigma) for improving processes & business systems to effectively identify, prioritize, communicate, and resolve quality issues
* Encourage all employees to be champions for quality and compliance
(Supervision Received) Works under only general direction. Independently determines and develops
approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
(Supervision Provided) May provide work direction and guidance to exempt and/or skilled nonexempt levels of employees; may be asked to evaluate performance of and assist in career development planning for team members.
Position Accountability / Scope
(Influence/Leadership) Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example,
providing guidance and work direction, and offering counsel. May lead a project team. Participates
in determining goals and objectives for projects. Influences middle management on technical or
business solutions. May interact with vendors.
(Planning/Organization) Plans and organizes non-routine tasks w/ approval. Initiates or maintains work
schedule. Establishes priorities of work assignments.
(Decision Making/Impact) Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.
EDUCATION AND EXPERIENCE YOU’LL BRING:
Minimum Education
Bachelor’s degree (Engineering/Life Sciences) plus 6+ years of related work experience with a strong
understanding of specified functional area, or an equivalent combination of education and work
experience. Advanced degree preferred.
Minimum Experience / Training Required
(Technical/Business Knowledge (Job Skills)) 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.
* Quality systems, risk management, and CAPA experience
* Engineering/lab experience with demonstrated use of Quality tools/methodologies
* Ability to travel approximately 10%
* Medical devices, pharmaceutical, or other FDA regulated industry experience preferred
* Supervisory experience preferred
* CQE, Lean/Six Sigma, and/or PMP certification preferred
(Cognitive Skills) 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 or 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.