CAPA Specialist at Abbott

Hangzhou, China

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Not SpecifiedCompensation

Junior (1 to 2 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, HealthcareIndustries

Requirements

Bachelor's Degree (≈16 years), preferably in engineering, healthcare, or science fields
Associate's Degree (≈13 years) with relevant medical device/quality system experience
Master's Degree (≈18 years) preferred
Minimum 2 years significant engineering and/or technical operational experience plus demonstrated competence
Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies
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 ability to lead multi-departmental project teams and resolve quality-related issues timely and effectively
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 skills with ability to effectively communicate at multiple levels in the organization
Ability to multitask, prioritize, and meet deadlines in a timely manner
Strong organizational and follow-up skills, as well as attention to detail
Ability to travel approximately 20%, including internationally
Ability to maintain regular and predictable attendance
ASQ CQT, CQE, CQA certification preferred
Six Sigma root cause analysis/problem solving training and experience preferred
Experience working in a broader enterprise/cross-division business unit model preferred

Responsibilities

Communicate 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
Assist with metrics and reporting on a regular basis in accordance with established procedures
Support team in the delivery and oversight of 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
Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments

Skills

CAPA

Six Sigma

Root Cause Analysis

Quality Assurance

FDA Regulations

Quality Tools

Metrics Reporting

Continuous Improvement

Abbott

Healthcare solutions in diagnostics and devices

About Abbott

Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.

Lake Bluff, IllinoisHeadquarters

1888Year Founded

IPOCompany Stage

HealthcareIndustries

10,001+Employees

Risks

Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.

Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.

Thermo Fisher's microfluidics expansion may increase competition for Abbott.

Differentiation

Abbott integrates continuous glucose monitoring with automated insulin delivery systems.

Abbott's microfluidic devices streamline diagnostic processes efficiently.

Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.

Upsides

Microfluidic technology offers cost-effective solutions in diagnostics.

Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.

Significant investments indicate strong market confidence in Abbott's healthcare solutions.

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