JOB DESCRIPTION:Sr. Quality Specialist The Opportunity This role offers the opportunity to lead complex quality and regulatory initiatives that directly impact patient safety, compliance, and business operations. The individual will be responsible for complaint assessments, regulatory reporting decisions, and the preparation of submissions such as MDRs, MedWatch, and Vigilance reports while serving as a key liaison with regulatory authorities and customers. The position also provides significant cross-functional leadership exposure, partnering with teams across complaint handling, customer service, medical affairs, product quality, and clinical research to drive process improvements and quality system effectiveness. In addition, the role owns critical supplier quality activities, including qualification and risk assessment processes, while independently driving projects, influencing stakeholders, and ensuring compliance across a global organization. This position is an onsite role based in Alameda, CA, with occasional domestic and international travel (up to 10%) required.
What You'll Work On- Independently lead groups and projects to resolve complex issues. analyze complex problems and identify their impact. establish probabilities. draw conclusions reflecting broad business needs. ensure compliance.
- Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.
- Establish regulatory reportability decisions using event investigation and regulatory decision models.
- Lead supplier quality assurance activities to ensure compliance with internal quality standards and applicable regulations, including ISO 13485, FDA QSR, MDR/IVDR, and other global requirements.
- Write Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transmission to the appropriate regulatory authorities.
- Compose written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to end use customers or regulatory bodies
- Cross-functionally lead alignment between departments and/or divisions which may include complaint handling, customer service, medical events, and product quality.
- Cross-functionally lead Quality System process improvements which may include training, corrective action and preventive action (CAPA) activities, equipment maintenance, product and process planning, quality audits, validation, product development/clinical research, design control activities, complaints, and post market surveillance.
- Work may require collaboration with other Division sites and/or other Abbott divisions.
- Responsible for completing documentation in a timely manner and in accordance with business standards.
- Travel up to 10% of the time both domestically and internationally to support organizational goals
- Understand and comply with applicable EHS policies, procedures and guidelines.
- Works under general direction; independently determines and develops approach to solutions; work is reviewed upon completion for adequacy in meeting objectives.
- Makes timely and effective decisions related to business issues within scope of responsibility; appropriately elevates high risk issues / decisions; identifies and quantifies risks and their consequences relative to the success of a project / task; recommends appropriate action; decisions or recommendations would typically achieve departmental / project objectives.
- Drives functional performance that ensures cross-functional standards and expectations are met
Required Qualifications- Bachelor's Degree or an equivalent combination of education and experience
- 5 years relevant experience, such as Quality, Compliance, Engineering, within a regulated environment, such as medical device, diagnostics, or pharmaceutical industries, to develop the competence required to meet the skills and responsibilities of the position.
- Knowledge of applicable US and non-US Quality System Requirements and other relevant regulations for medical devices. Previous experience with regulatory body.
- Knowledge of software regulations and compliance (21 CFR Part 11)
- Knowledge of ISO 13485; knowledge of consumer regulations a bonus.
- Knowledge of quality management techniques and the application and principles of quality engineering. Strong knowledge and application of concepts, practices and procedures. Ability or aptitude to work on problems that are complex in scope where analysis of situations or data involves multiple competing factors. Understanding of statistics.
- Ability to form and develop interpersonal, professional relationships; display socially and professionally appropriate behavior.
- Ability to work independently and in groups; ability to work cross-functionally.
- Demonstrated initiative and problem-solving skills and critical-thinking skills.
- Ability and aptitude to use various types of databases and other computer software.
- Ability to prioritize. Strong organizational and project management skills.
- Ability or aptitude to lead without direct authority
Apply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
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Divisional InformationMedical Devices
General Medical Devices:
Our medical devices 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.
CRM
As a global leader in Cardiac Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.
Diabetes
We're focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We're revolutionizing the way people monitor their glucose levels with our new sensing technology.
Vascular
Abbott Vascular provides innovative, minimally invasive, and cost-effective products for the treatment of vascular disease.
Neuromodulation
Our Neuromodulation business includes implantable devices compatible with mobile technology to help people who suffer from chronic pain and movement disorders. These non-opioid therapies allow us to provide interventional pain therapy to patients throughout the pain continuum.
Structural Heart
Structural Heart Business Mission: Why We Exist
Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.
EP
In Abbott's Electrophysiology (EP) business, we're advancing the treatment of heart disease through breakthrough medical technologies in atrial fibrillation, allowing people to restore their health and get on with their lives.
HF
In Abbott's Heart Failure (HF) business, we're developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
Diagnostics
We're empowering smarter medical and economic decision-making to help transform the way people manage their health at all stages of life. Every day, more than 10 million tests are run on Abbott's diagnostics instruments, providing lab results for millions of people.
Our Point of Care diagnostic portfolio spans key health and therapeutic areas, including infectious disease, cardiometabolic, informatics, and toxicology.
Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.
Our rapid diagnostics solutions are helping address some of the world's greatest healthcare challenges.
Our molecular division delivers best-in-class innovative testing solutions for people around the world to provide answers to life's critical health decisions. We help people live full and healthy lives through our accessible, molecular-based solutions.
Nutrition
Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac®, PediaSure®, Pedialyte®, Ensure®, and Glucerna® - to help them get the nutrients they need to live their healthiest lives.
The base pay for this position is $90,000.00 - $180,000.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Operations Quality
DIVISION:LNGO Lingo
LOCATION:United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:Yes, 10 % of the Time
MEDICAL SURVEILLANCE:No
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), Keyboard use (greater or equal to 50% of the workday)
