Director, Quality Assurance - Abbott Vascular at Abbott

Temecula, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Healthcare, Medical DevicesIndustries

Requirements

Bachelor's degree required in a related field or an equivalent combination of education and work experience
Master's degree preferred
Minimum 12 years of relevant career experience required

Responsibilities

Recruits, coaches and develops organizational talent. Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives
Monitors and ensures compliance with company policies and procedures (e.g. compliance with FDA, BSI regulations, etc.)
Recommends and implements changes to the Quality System as the result of changing regulations, continuous improvement and/or business needs
Ensures rigorous and diligent Design Control practices, including data-driven stage-gate reviews, robust characterization and validation, and stakeholder-focused success criteria for all stages, including manufacturing transfer and commercial readiness
Ensures that appropriate specifications are assigned for materials, process parameters, in-process and finished good testing, etc., and that these specifications are justified with appropriate characterization and validation data
Demonstrates strong product knowledge, problem solving, change management, results orientation, and data-driven decision making
Builds strategic partnerships with internal stakeholders, including operations, regulatory affairs, R&D, clinical, operations QA, and ensures alignment of goals and critical success factors for product development, approval, and manufacturing needs
Interacts internally and externally with executive level management, outside regulatory agencies, customers, vendors and/or suppliers
Creates mid- to long-range QA R&D plans to carry out objectives established by top management; develops and calculates a budget for one or more departments to meet organizational goals; forecasts future departmental or group needs including human and material resources and capital expenditures; determines and establishes organizational structure and supervisory relationships subject to top management approval
Typically makes decisions that translate programs established by top management into operational plans and schedules; work is performed without appreciable direction

Skills

Key technologies and capabilities for this role

Design ControlQuality AssuranceProduct ValidationRegulatory ComplianceTalent DevelopmentTeam LeadershipOrganizational Development

Questions & Answers

Common questions about this position

What benefits does Abbott offer?

Abbott provides free medical coverage in the Health Investment Plan (HIP) PPO medical plan, an excellent retirement savings plan with high employer contribution, tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit for earning a bachelor’s degree.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What key skills are needed for the Director, Quality Assurance role?

The role requires strong product knowledge, problem solving, change management, results orientation, data-driven decision making, and expertise in Design Control practices including characterization, validation, and stage-gate reviews.

What is the company culture like at Abbott?

Abbott fosters a diverse workplace that enables all participants to contribute to their full potential, supports career development and growth, and is recognized as a great place to work with emphasis on compliance, continuous improvement, and work that matters.

What makes a strong candidate for this position?

A strong candidate excels in recruiting and developing talent, ensuring regulatory compliance, implementing Quality System changes, building strategic partnerships with stakeholders, and demonstrating leadership in Design Control and data-driven decision making.

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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