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.
Structural Heart
Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease. We aim to lead the markets we serve by requiring the solutions we offer customers provide an improved benefit/risk profile as compared to existing standards of care; a performance threshold that by definition, guides and ensures the productive output of our engineering, business development, and clinical research efforts result in outcomes that advance the standard of care.
We are recruiting for a Quality Assurance Supervisor (M-F / 1st Shift) to join our team in the Menlo Park, CA location. In this role, you are responsible for implementing and maintaining the effectiveness of the quality system by managing the quality assurance manufacturing operation, systems, and procedures to support incoming, in-process, and final product release/distribution testing to meet product quality requirements.
WHAT YOU’LL DO
- Ensures the appropriate quality oversight during receiving inspection, testing, and release of medical device components
- Provides direct supervision to professional, direct or indirect labor staff, ensuring that compliance is maintained and that employees are trained and following the required division/site level policies and procedures.
- Ensures that plans are implemented, and milestones are achieved.
- Collaborate with the Site Quality Head in areas of risk, which may have an adverse effect on product quality/performance, project completion and/or safety.
- Assists and advises on pertinent quality issues as they arise during plant operations.
- Supports and contributes to strategies for assessing site GMP processes and implementation to ensure compliance with industry standards.
- Participates in internal and external audits and represents the site as a SME or Process Community member.
- Leads complex quality discussions across various departments including, as needed, external suppliers.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
- Bachelor's Degree in Biology, Chemistry, Life Sciences, Engineering, or another related technical field
- 2 years of general quality control and/or inspection experience within a regulated industry (ie: medical device, pharmaceutical, defense, aerospace, etc) including experience performing quality inspections and/or quality engineering
- 6 months of experience in a supervisory position/directly leading a team
- Demonstrated experience evaluating and determining risk from a quality perspective
- Excellent verbal and written communication skills, with ability to communicate to all levels of the organization
- Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization
- Proficient in MS Office (Word, Excel, PowerPoint, Outlook)
Preferred
- Advanced level degree in Biology, Chemistry, Life Sciences, Engineering, or another related technical field
- Medical device experience
- Experience with Lean Manufacturing
- Experience with GMP, FDA, ISO and USDA regulations
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.