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Senior Specialist Quality Assurance - Princeton, United States - Abbott Laboratories company
Description
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 114,000 colleagues serve people in more than 160 countries.Working at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life.
You'll also have access to:
Career development with an international company where you can grow the career you dream of.
Free medical coverage for employees* via the Health Investment Plan (HIP)
PPOAn excellent retirement savings plan with a high employer contributionTuition reimbursement, theFreedom 2 Savestudent debt program, andFreeUeducation benefit - an affordable and convenient path to getting a bachelor's degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.
The OpportunityAbbott Point of Care is a global leader in providing critical medical diagnostic and data management products for rapid blood analysis that are intuitive, reliable, and cost-effective.
Our iWhat You'll Work OnCommunicate confidently and effectively with all levels of management, peers, and key stakeholders, including timely escalation of quality issues.
Participate in, or lead, the completion of CAPA projects, assuring compliance, quality, and timeliness of records.Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem-solving skills).Independently investigate, gather data, and perform preliminary analysis.
Process requests, ensuring owners are assigned, and timely responses and approvals are provided in alignment with quality goals.
Lead meetings and communications for CAPA updates, information, and concerns.
Responsible for assisting with metrics and reporting regularly by established procedures.
Support team in the delivery and oversight of the CAPA training program.
Assist in the initiation, processing, and completion of CAPA records in the electronic system.
Execute and provide on-time completion of Quality Assurance engineering deliverables.
Provide support and subject matter expertise during audits and inspections.
Lead and/or contribute to continuous improvement initiatives and projects.
Mentor lower-level CAPA engineers.
Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
Required QualificationsSignificant engineering and/or technical operational experience plus demonstrated competence.
Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
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 communication with the ability to effectively communicate at multiple levels in the organization. Multitasks prioritizes and meets deadlines promptly.
Strong organizational and follow-up skills, as well as attention to detail.
Preferred QualificationsPrior medical device experience is preferred.
Experience working in a broader enterprise/cross-division business unit model is preferred.
ASQ CQT, CQE, andCQA certifications are preferred.
Six Sigma root cause analysis/problem-solving training and experience preferred.
www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life.
Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us , on Facebook , andonTwitter @AbbottNews.
The base pay for this position is $72,700.00 – $145, In specific locations, the pay range may vary from the range posted.
