JOB DESCRIPTION:The Opportunity Personalized healthcare is the future. Bio-wearable technology will digitize, decentralize, and democratize healthcare, enabling consumers to take control of their own health. Diabetes is a growing problem worldwide, and at Abbott Diabetes Care (ADC) we are helping people with diabetes lead healthier, happier lives.
Consistent and accurate glucose monitoring is the foundation of any diabetes management plan, and we're committed to continuous improvement in the way patients and professionals measure, track and analyze glucose levels. ADC is responsible for the development and launch of new digital products based on the FreeStyle Libre platform, the world's #1 continuous glucose monitoring (CGM) solution.
This position will be based out of Abbott Diabetes Care Division in Alameda, CA and the individual will be expected to be onsite Mon-Fri. The position will be responsible for driving CAPA projects through its entire life cycle, mentor lower-level engineers, while strategizing continuous process improvements that aid in improving the CAPA program.
What You'll Work On- Lead, mentor and motivate a team of Quality Engineers.
- Communicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
- Accountable for leadership and oversight of the CAPA system, and associated deliverables.
- Provide guidance, insight and training to the team and the wider business around CAPA process, quality standards, and regulatory requirements.
- Lead and/or contribute to continuous improvement initiatives and projects.
- Provide subject matter expertise during audits and inspections.
- Represent CAPA QA in cross functional meetings (site and division).
- High proficiency leading meetings and communications for QA system information, concerns, and updates.
- Lead, develop, and mentor others with QA data analysis, trending, and reporting. High proficiency with reporting and publishing weekly, monthly, and quarterly metrics.
- Adept at staying current with organizational and industry information and routinely mentors/leads other members of the organization on quality assurance practices.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Required Qualifications- B.S. in Engineering, Technical Field, Life Science or closely related discipline. Equivalent combination of education and work experience will be accepted
- Masters degree preferred
- Minimum 6 years in Quality or related field experience.
- Previous CAPA and/or Quality Assurance/engineering experience and demonstrated use of quality tools/methodologies.
Preferred Qualifications- Prior medical device experience preferred.
- Detailed knowledge of FDA Quality System Regulations (21 CFR Part 820), GMP, and ISO 13485: 2016.
- Solid communication and interpersonal skills.
- Demonstrated and impactful project management and leadership skills, including the ability to lead multi-departmental project teams and resolve quality-related issues in a timely and effective manner.
- Advanced computer skills, including statistical/data analysis and report writing skills.
- 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 20%, including internationally.
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
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
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
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:ADC Diabetes Care
LOCATION:United States > Alameda : 1360-1380 South Loop Road
ADDITIONAL LOCATIONS:WORK SHIFT:Standard
TRAVEL:No
MEDICAL SURVEILLANCE:No
SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
